ANN ARBOR, Mich., Feb. 2, 2009 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today reported that one patient enrolled in the Company’s U.S. Phase II IMPACT-DCM clinical trial experienced a serious adverse event associated with anesthesia management during treatment at one of the active clinical sites. According to the results of an internal review conducted at the clinical site, and a second review by the trial’s independent Data Safety Monitoring Board (DSMB), this event has been attributed to anesthesia administration and management in this single patient. Furthermore, these two reviews separately determined that this event was not related to the surgical approach or the use of Aastrom’s Cardiac Repair Cells (CRCs) in this procedure. This patient has received appropriate treatment, has fully recovered from this isolated event and continues to be monitored in accordance with the study protocol. In compliance with regulatory requirements and standard operating procedures, this event was reported directly to the U.S. Food and Drug Administration (FDA) and Aastrom immediately took the initiative to suspend patient enrollment at the clinical site where the event took place, pending an internal review and the implementation of a corrective action plan.

In accordance with our commitment to the highest safety standards for participants in this trial, Aastrom has complied with a subsequent verbal communication from the FDA that the IMPACT-DCM trial be placed on clinical hold at all trial sites pending completion of a more comprehensive review of this event. Aastrom is working closely with the FDA to provide any information required in order to expedite this review and to resolve this matter so that patient enrollment into the IMPACT-DCM trial can resume as soon as possible.

Notwithstanding the hold, the FDA authorized Aastrom to proceed with the CRC treatment for one patient previously enrolled in the IMPACT-DCM clinical trial. This patient was treated last week. In addition, follow-up monitoring of patients who have previously been treated in the IMPACT-DCM trial is continuing in accordance with the study protocol.

“Patient safety has been and continues to be the highest priority for everyone involved in Aastrom clinical trials,” stated Elmar R. Burchardt, MD, PhD, Vice President, Medical Affairs at Aastrom. “We believe, and all available information indicates, that this is an isolated incident unrelated to the safety of our CRC cell product. We are proactively and rapidly supporting the FDA review of this event and look forward to continuing treatment of this critically ill patient population in the IMPACT-DCM trial.”

IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with dilated cardiomyopathy (DCM) in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom’s CRCs, an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient’s own bone marrow.

About Dilated Cardiomyopathy (DCM)
Many of the 5.5 million people in the U.S. suffering from severe heart failure have DCM, a condition where expansion of the patient’s heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applying TRC technology to cardiac and vascular tissue regeneration. The company is currently focused on cardiovascular regeneration and is conducting a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial).

ANN ARBOR, Mich., Nov. 20, 2008 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced that the first patient has been treated in its randomized, controlled, prospective, open-label IMPACT-DCM clinical trial. Currently enrolling patients at The Methodist Hospital in Houston, TX, Baylor University Medical Center in Dallas, TX and The University of Utah School of Medicine in Salt Lake City, UT, the U.S. Phase II clinical trial is designed to evaluate the Company’s Cardiac Repair Cells (CRCs) in the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure. Dr. Amit Patel, Associate Professor of Surgery at the University of Utah School of Medicine, is the National Principal Investigator for this trial.

IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into human heart muscle for the treatment of DCM-related congestive heart failure. Patients are treated with Aastrom’s CRCs, an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells designed to treat patients with end-stage DCM. CRCs, manufactured using Aastrom’s Tissue Repair Cell (TRC) technology, previously received Orphan Drug Designation from the FDA for the treatment of DCM.

“Following our initial positive experience with compassionate use treatments in Germany, we are pleased to advance this promising cardiac regeneration treatment to the clinic in the U.S.,” said George Dunbar, President and Chief Executive Officer of Aastrom. “We are pleased with the momentum this trial is gathering. Three of the five clinical sites are currently ready to enroll patients, and we look forward to having all five sites actively recruiting patients into this multi-center study.”

The first patient surgery in the IMPACT-DCM trial took place at the Methodist DeBakey Heart & Vascular Center (Methodist) in Houston, TX. The procedure was performed by Dr. Brian Bruckner, Cardiac Surgeon at Methodist and Principal Investigator of the trial at the clinical site; Dr. Michael Reardon, Chief of Cardiac Surgery at Methodist and a Co-Investigator of the trial; and Dr. Matthias Loebe, Transplant Surgeon at Methodist and a Co-Investigator of the trial.

The Phase II study seeks to enroll 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the U.S. Participants must have a left ventricular ejection fraction (LVEF) of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. The study protocol states that patients in each group will receive standard medical care and 75% of patients will be treated with CRCs through direct injection into the heart muscle during minimally invasive open heart surgery. While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including LVEF, heart failure stage and other measures of cardiac function will be monitored. The Company intends to follow patients in the study for 12 months post treatment.

“This is the first clinical trial designed to target both ischemic and non-ischemic DCM,” said Dr. Elmar Burchardt, Vice President, Medical Affairs of Aastrom. “In the U.S. alone, there are 1.8 million patients with severe heart failure, which includes 120,000-150,000 patients suffering from DCM.”

Many of the 5.5 million people in the U.S. suffering from severe heart failure have DCM, a condition where expansion of the patient’s heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.

About Orphan Drug Designation
The Orphan Drug Designation is granted to development-stage products, such as Aastrom’s CRCs, that offer potential therapeutic value in the treatment of rare diseases and conditions. With this designation, Aastrom may be entitled to several benefits prior to approval, including an expedited FDA review, the reduction or even elimination of filing fees, and the availability of possible tax credits, and will be entitled to seven years of marketing exclusivity once the product receives FDA approval.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applying TRC technology to cardiac and vascular tissue regeneration. The company is currently focused on cardiovascular regeneration and is conducting a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial).

ANN ARBOR, Mich., Oct. 30, 2008 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced that the 30th patient has been treated in the Company’s U.S. Phase IIb RESTORE-CLI clinical trial. This milestone marks the first step toward interim data retrieval from this clinical trial evaluating Aastrom’s Vascular Repair Cells (VRCs) in the treatment of patients suffering from the most severe form of peripheral arterial disease (PAD), critical limb ischemia (CLI). After the 30th patient has been followed for one year the Company will be able to unblind and analyze the interim data.

The RESTORE-CLI clinical trial is a prospective, controlled, randomized, double-blind, multi-center study that is reviewed quarterly by a sponsor-appointed, independent Data and Safety Monitoring Board (DSMB). The DSMB is composed of third-party experts in vascular surgery, cardiovascular medicine, stem cell research and biostatistics. The DSMB has unblinded access to all available patient data. They review patient safety as well as efficacy information on an ongoing basis. At their September 24, 2008 meeting, the independent DSMB unanimously recommended continuation of the study.

“Treating the 30th patient in the RESTORE-CLI trial is a significant clinical accomplishment for Aastrom as we are now able to target the timing for the next milestone — reporting interim data from this first set of critically ill patients,” said George Dunbar, President and Chief Executive Officer of Aastrom. “These patients face a high risk of major limb amputation and may benefit from Aastrom’s VRC treatment.”

Approximately 10 million people in the U.S. suffer from PAD; of this group, 900,000 suffer from the most severe form, CLI, which leads to 100,000 amputations per year. PAD is a chronic disease that progressively restricts blood flow in the limbs and can lead to serious medical complications. This disease is often associated with other clinical conditions, including hypertension, cardiovascular disease, hyperlipidemia, diabetes, obesity and stroke. The term CLI is used to describe patients with chronic ischemia-induced pain (even at rest), ulcers, tissue loss or gangrene in the limbs. CLI represents the end stage for PAD patients.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applying TRC technology to cardiac and vascular tissue regeneration. The Company is currently focused on cardiovascular regeneration and is conducting a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia patients (the RESTORE-CLI trial).

ANN ARBOR, Mich., Oct. 28, 2008 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, announced that the Company received notification from the Listings Qualifications Department of The Nasdaq Stock Market LLC (”NASDAQ”) that, given the current extraordinary market conditions, NASDAQ had suspended enforcement of the rules requiring a minimum $1.00 per share closing bid price and a minimum market value of publicly held shares through Friday, January 16, 2009. As previously announced, Aastrom had been given until December 15, 2008 to evidence a closing bid price of $1.00 or more for a minimum of ten consecutive business days to regain compliance. As a result of NASDAQ’s suspension, Aastrom now has until March 20, 2009 to regain compliance with the $1.00 minimum closing bid price rule in order to remain listed on the Nasdaq Capital Market.

NASDAQ stated in its Issuer Alert #2008-005, dated October 16, 2008, that it believes this temporary suspension will permit companies to focus on running their businesses, rather than satisfying market based requirements that are largely beyond their control in the current environment. This ruling also aims to increase investor confidence in NASDAQ companies currently facing the prospect of delisting. NASDAQ stated it will not take any action to delist any security for these concerns during the temporary suspension and it will continue to monitor companies to determine if they regain compliance during the temporary suspension.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applications of the technology to cardiac and vascular regeneration. The Company currently has a cardiovascular regeneration product in Phase II development for the treatment of dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and critical limb ischemia (called the RESTORE-CLI trial).

ANN ARBOR, Mich., Sept. 29, 2008 (GLOBE NEWSWIRE) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced that Institutional Shareholder Services, Inc. (ISS), a wholly-owned subsidiary of RiskMetrics Group, Inc., one of the nation’s leading proxy advisory firms, has recommended that Aastrom shareholders vote “FOR” both the declassification of the Board of Directors which, if passed, will result in the annual election of all Directors, and the elimination of the supermajority vote requirement at the Annual Meeting of Shareholders scheduled for October 17, 2008.

With regard to the declassification of the Aastrom Board of Directors, the report stated: “ISS commends management for submitting this proposal, which demonstrates a commitment to shareholders’ interests.”*

The report also commented on Aastrom’s proposal to eliminate the supermajority vote requirement as follows: “ISS maintains that a simple majority of voting shares should be sufficient to effect changes in a company’s corporate governance. Requiring more than a simple majority may permit management to entrench itself by blocking amendments that are in shareholders’ best interests. Therefore, we support the elimination of the supermajority vote requirement and commend the company for submitting this proposal.”*

The Board of Directors of Aastrom unanimously recommends that shareholders vote “FOR” both of these proposals which are considered to be good corporate governance practices. These proposals are described in detail in the fiscal year 2008 Proxy Notice and Statement previously provided to shareholders of record as of September 2, 2008.

Aastrom and its Board of Directors encourage all shareholders to vote their shares promptly by phone, Internet, or by mailing their proxy card. If shareholders have any questions or need assistance in voting their shares, they may contact MacKenzie Partners toll-free at (800) 322-2885 or collect at (212) 929-5500, or Aastrom’s Investor Relations Department collect at (734) 930-5777.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Ongoing development activities are focused on applications of the technology to cardiac and vascular regeneration. The Company currently has a cardiovascular regeneration product in Phase II development for the treatment of dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and critical limb ischemia (called the RESTORE-CLI trial).

ANN ARBOR, Mich., Jun 18, 2008 – Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced that on June 18, 2008 the Company received a notice from The Nasdaq Stock Market (Nasdaq) informing the Company, that pursuant to Nasdaq’s previous deficiency letter of December 20, 2007, Aastrom had not regained compliance with Nasdaq Marketplace Rule 4310(c)(4) related to the minimum closing bid price of the Company’s common shares by June 17, 2008. The notice stated that because Aastrom met all initial inclusion criteria for the Nasdaq Capital Market set forth in Marketplace Rule 4310(c) on June 17, 2008, except for the minimum closing bid price requirement, in accordance with Marketplace Rule 4310(c)(8)(D) Aastrom will now be provided an additional 180 calendar day compliance period, or until December 15, 2008, to regain compliance. At this time, this notification has no effect on the continued listing of Aastrom’s common stock on the Nasdaq Capital Market.

Aastrom can regain compliance with the minimum closing bid price rule anytime before December 15, 2008, if the bid price of its common stock closes at $1.00 or higher for a minimum of ten consecutive business days. Nasdaq may, in its discretion, require the Company to maintain a minimum closing bid price of at least $1.00 per share for a period in excess of ten consecutive business days (but generally no more than 20 consecutive business days) before determining that Aastrom has demonstrated the ability to maintain long-term compliance. If Aastrom does not regain compliance during this additional compliance period, Nasdaq will provide written notice to Aastrom that its securities will be delisted from the Nasdaq Capital Market. At such time, Aastrom would be able to appeal the delisting determination to a Nasdaq Listing Qualifications Panel.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting cardiovascular, bone and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Currently, the Company has a cardiovascular regeneration product in Phase II development for the treatment of dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), and a preclinical research program targeting unmet needs in neural health. Aastrom product candidates to treat DCM and osteonecrosis of the femoral head have been designated for orphan drug status by the FDA. For more information, visit Aastrom’s website at www.aastrom.com.

ANN ARBOR, Mich., Jun 17, 2008 – Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced plans to initiate a 40 patient U.S. Phase II clinical trial to study the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient’s own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure. Aastrom is now authorized under U.S. Food & Drug Administration (FDA) regulations to initiate its first Investigational New Drug (IND) clinical trial for cardiac regeneration. CRCs, manufactured using Aastrom’s Tissue Repair Cell (TRC) technology, previously received Orphan Drug Designation from the FDA for the treatment of DCM.

“This landmark trial is the first in the world to target both ischemic and non-ischemic DCM patients. It is also the first trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the source of the problem, the heart muscle, for the treatment of congestive heart failure due to DCM,” stated David A. Bull, M.D., Professor of Surgery and Chief of Cardiothoracic Surgery at the University of Utah School of Medicine. “Aastrom’s unique technology is able to produce a mixed cell population that we believe may be efficacious for treating these end-stage patients and is our primary motivation for participating in the trial.”

The randomized, controlled, prospective, open-label, Phase II study will seek to enroll 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the U.S. Participants must have a left ventricular ejection fraction of less than or equal to 25% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. All patients in each group will receive standard medical care and 75% of the patients will be treated with CRCs through direct injection into the heart muscle during open heart surgery. While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function parameters as well as heart failure stage will be monitored. Patients will be followed for 12 months post treatment.

“Aastrom’s trial is targeting critically ill patients with heart failure. These patients, with enlarged, weakened hearts, are at the end-stage of their disease and currently have no treatment options other than a heart transplant,” said Mariell Jessup M.D., Professor of Medicine and Medical Director of Heart Failure and Transplantation, at the University of Pennsylvania Health System. “Without a new therapeutic approach the majority of these patients will continue to decline and less than 40% will survive five years.”

There are currently 5.5 million people in the U.S. suffering from chronic heart failure. A subset of these patients has DCM, a chronic cardiac disease where expansion of the patient’s heart reduces the pump function to a point that the normal circulation of blood cannot be maintained. Patients with DCM typically present with symptoms of congestive heart failure, including severe limitations in their physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends on the stage of the disease but is characterized by numerous health problems and a very high mortality rate.

“After initial positive patient experience in the EU, we are pleased to be advancing our promising CRC program into the clinic in the U.S.,” said George Dunbar, President and Chief Executive Officer of Aastrom. “The IND approval for a Phase II trial to treat patients suffering from DCM supports our decision to focus our efforts and resources primarily on cardiac regeneration. As we move our cardiac development program forward, we will stop enrolling patients in our ON-CORE clinical trial for bone regeneration until we identify a partner to work with us to complete that effort. Patients who have already been treated in the ON-CORE trial will be followed by their physicians for the full 24 month follow-up period. Our RESTORE-CLI clinical trial targeting critical limb ischemia will continue as planned.”

About Orphan Drug Designation
The Orphan Drug Designation is granted to development-stage products, such as Aastrom’s CRCs, that offer potential therapeutic value in the treatment of rare diseases and conditions. The Company may be entitled to several benefits prior to approval, including an expedited FDA review, the reduction or even elimination of filing fees, and the availability of possible tax credits, and will be entitled to seven years of marketing exclusivity once the product receives FDA approval.

About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting cardiovascular, bone and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Currently, the Company has a cardiovascular regeneration product in Phase II development for the treatment of dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), and a preclinical research program targeting unmet needs in neural health. Aastrom product candidates to treat DCM and osteonecrosis of the femoral head have been designated for orphan drug status by the FDA. For more information, visit Aastrom’s website at http://www.aastrom.com/.

ANN ARBOR, Mich., May 5, 2008 (PrimeNewswire via COMTEX News Network) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced that its Board of Directors will withdraw its proposal to shareholders for approval of the grant of discretionary authority to Aastrom’s Board of Directors to amend the Company’s Restated Articles of Incorporation to effect a reverse stock split. A Special Meeting of Shareholders had been convened on April 8, 2008 and adjourned until May 6, 2008 to allow more time for shareholders to cast their votes on the proposal. More than seventy-five percent (75%) of the shares that were actually voted were cast in favor of the reverse stock split proposal. However, approval of two-thirds (or 66-2/3%) of all outstanding shares was required by Aastrom’s charter for this proposal. Due to the high number of outstanding shares that were not voted at all, the two-thirds requirement was not obtained.

“The Company remains focused on accelerating its clinical programs that address significant unmet medical needs in the vascular, bone and cardiac regeneration therapeutic areas. Aastrom’s management and Board of Directors will continue to evaluate options to preserve our current Nasdaq Capital Market listing and to fund our promising clinical programs,” stated George Dunbar, President and Chief Executive Officer of Aastrom.

About Aastrom Biosciences, Inc.
Aastrom is a leading regenerative medicine company engaged in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Currently, the Company has a vascular regeneration product in clinical development for the treatment of critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), a cardiac regeneration product in clinical development for dilated cardiomyopathy and a preclinical research program targeting unmet needs in neural health. Aastrom product candidates to treat osteonecrosis of the femoral head and dilated cardiomyopathy have been designated for orphan drug status by the FDA. For more information, visit Aastrom’s website at www.aastrom.com/.

ANN ARBOR, Mich., Apr 17, 2008 (PrimeNewswire via COMTEX News Network) — Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine company, today announced encouraging data from the first two compassionate use patients treated with the Company’s autologous stem cell therapy for dilated cardiomyopathy (DCM), a type of severe chronic heart failure. Hans Michael Klein, M.D., Professor of Cardiac Surgery at the Dusseldorf University Hospital in Dusseldorf, Germany performed the first human application of Aastrom’s Cardiac Repair Cell (CRC) product through direct injection into the heart muscle during open heart surgery in two patients late in 2007. Due to the promising results from these first patients using the CRC treatment, Dr. Klein’s clinical activity is ongoing and additional patients are being evaluated for this treatment.

“I have had the opportunity to treat over 70 severe heart failure patients with cell therapy during my career. Until now, the most severe patients had little chance for long-term treatment success. CRCs have the potential to become the new standard of care for patients suffering from DCM,” said Dr. Klein. “These patients have a very low quality of life and fewer than 40% survive five years. The improvements we observe in their heart function allow us to measure their progress. We have noted this parallels the substantial improvement in the patient’s symptoms and their heart failure stage. These first two cases have been very positive, so I am eager to continue this clinical activity with Aastrom’s CRC product.”

Dr. Klein’s first patient, a 74 year old male diagnosed with ischemic dilated cardiomyopathy who also suffered from extensive three-vessel coronary heart disease, renal insufficiency and unstable angina pectoris (chest pain), was treated with CRCs in November 2007. This patient met the clinical criteria for the most advanced stage of heart failure (class IV) under the New York Heart Association classification guidelines, with severe shortness of breath even without physical activity and when lying in bed. Prior to the CRC treatment his left ventricular ejection fraction was 10% (the percentage of blood pumped out of the heart with each contraction), below the normal range of 60-75% for a typical healthy person. After the CRC treatment and upon discharge from the hospital in January 2008, this patient’s ejection fraction had improved to 25-30% and clinical improvement of his heart failure stage had been noted.

The second patient, a 69 year old female diagnosed with severe DCM, also suffered from extensive three-vessel coronary heart disease and had experienced multiple previous heart attacks. This patient had previously undergone coronary artery bypass grafting, several interventional treatments by catheter and had no other treatment options when she was admitted to the hospital. Prior to the CRC treatment her ejection fraction was 25-30%, and upon discharge from the hospital in February 2008 her ejection fraction had improved to 45%.

“Our CRC product is distinguished from other cardiac cell therapies because it is an autologous, mixed cell product that contains large doses of stem and progenitor cells that may be ideal for patients with end-stage cardiac diseases,” said Elmar R. Burchardt, MD, PhD, Aastrom’s Vice President, Medical Affairs. “Dr. Klein’s clinical experiences using our CRCs are extremely important as we develop our U.S. clinical program. We will continue to target the most severe patients suffering from DCM who, other than heart transplant, have no treatment options.”

Aastrom’s proprietary CRCs received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of DCM in January 2007. In the U.S., Orphan Drug Designation provides a variety of incentives, including seven years of market exclusivity following FDA approval.

Aastrom is on track for submission of a U.S. Investigational New Drug (IND) application for a cardiac regeneration clinical trial using CRCs during 2008. The Company’s ultimate target market for CRCs in the U.S. is 1.8 million no-option heart failure patients, which includes patients suffering from DCM.

About Aastrom Biosciences, Inc.

Aastrom is a leader in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s proprietary Tissue Repair Cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. The TRC technology platform has positioned Aastrom to advance multiple products into clinical development. Currently, the Company has a vascular regeneration product in clinical development for the treatment of critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), a cardiac regeneration product in clinical development for dilated cardiomyopathy and a preclinical research program targeting unmet needs in neural health. Aastrom product candidates to treat osteonecrosis of the femoral head and dilated cardiomyopathy have been designated for orphan drug status by the FDA. For more information, visit Aastrom’s website at www.aastrom.com/. (astmc)

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This document contains forward-looking statements, including without limitation, statements concerning clinical trial plans and expectations, clinical activity timing, intended product development and commercialization objectives, adequacy of existing capital to support operations for a specified time, future capital needs, and potential advantages and application of Tissue Repair Cell (TRC) Technology, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom’s Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.