Aastrom Biosciences has initiated its US Phase IIb prospective, controlled, randomised, double-blind, multi-centre clinical trial to treat patients suffering from peripheral arterial disease (PAD). The company will use its Tissue Repair Cell (TRC)-based product to treat critical limb ischaemia (CLI) in this patient population.
TRC-based products are a unique cell mixture of stem and progenitor cells, produced from a small amount of bone marrow taken from the patient. TRC-based products have been used in over 240 patients.
The double-blind study is expected to enrol 120 patients, randomised into two patient groups, to evaluate the safety and efficacy of the TRC-based product in the treatment of CLI. The treatment group will receive intramuscular injections of the TRC product into the affected limb; the control group will receive intramuscular injections with an electrolyte solution (without cells). Both groups will receive the standard of care appropriate for their medical condition.
Patients from both groups will be followed for a period of 12 months, post-treatment. The primary objective of the clinical trial is to assess the safety of the TRC-based product in CLI patients. Secondary objectives include assessing amputation rates, wound closure and blood flow in the affected limbs, patient quality of life, and the reduction of pain and analgesic use. Once the first 30 patients have completed the 12-month follow-up, Aastrom will analyse the interim results from these patients. Data gathered from this clinical trial will provide the scientific and statistical basis for an anticipated pivotal trial in the vascular regeneration area.
Aastrom initiated patient enrollment in this clinical trial after receiving Investigational New Drug (IND) approval from the FDA and Institutional Review Board (IRB) approval from several clinical sites. This is Aastrom's second study evaluating TRC-based therapy in patients with critical limb ischaemia. The TRC-based product is also being used in a clinical trial being conducted at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.
"This is a landmark study in terms of the number of patients to be enrolled, and the scientific rigor of its design. If this therapy proves successful in these critically ill patients, it will have implications beyond the treatment of limb ischaemia, which may apply to all ischaemic diseases," stated Dr Anthony J Comerota, Director, Jobst Vascular Center and Adjunct Professor at the University of Michigan. "This is an intuitively attractive treatment concept as it takes advantage of the patients' own cells to restore blood flow and to regenerate blood vessels in patients whose native arterial circulation is thought to be irreversibly damaged."
The company is also developing programmes for TRC-based therapies to address cardiac and neural regeneration indications. TRC products have received Orphan Drug Designation from the FDA for use in the treatment of osteonecrosis of the femoral head and the treatment of dilated cardiomyopathy.
"Receiving FDA approval to initiate our US PAD clinical trial, and commencing patient recruitment are major milestones for Aastrom's vascular regeneration programme," said George Dunbar, CEO and President of Aastrom. "This is a key programme for us as we develop and commercialise cell-based therapies for regenerative medicine. We expect our TRC-based product for vascular regeneration to be an important part of our expanding therapeutic portfolio."
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