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Aastrom Announces Positive Interim Results from Phase I/II Study Involving use of Vascular Repair Cells in Patients with Critical Limb Ischemia
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Aastrom Biosciences, Inc. has announced positive interim results from two separate research groups utilizing autologous stem cell products manufactured with the Company's proprietary Tissue Repair Cell (TRC) Technology platform.
The first study reported positive results from the use of Aastrom Vascular Repair Cells (VRCs) in the treatment of chronic diabetic foot wounds associated with critical limb ischemia (CLI).
In another presentation, positive results from the use of Aastrom Bone Repair Cells (BRCs) in the treatment of osteonecrosis of the femoral head were presented. Primary investigators from each of these research groups presented data at the 2nd Congress of the German Society for Stem Cell Research in Wurzburg, Germany.
In an oral presentation, Dr. Bernd Stratmann of the Diabetes Center at the Heart and Diabetes Center in North Rhine-Westphalia (Center), Bad Oeynhausen, Germany, presented interim results from the first 13 patients treated in a multi-arm Phase I/II single-center clinical trial to evaluate the safety of VRCs and normal bone marrow cells in the treatment of chronic diabetic foot wounds associated with CLI.
Results reflect treatment experience from: four diabetic patients with ischemia-related chronic tissue ulcers who were treated with Aastrom VRCs, a cell mixture derived from the patient's bone marrow that is processed using TRC Technology to generate large numbers of predominantly mesenchymal stem and early progenitor cells; seven patients who were treated with normal bone marrow cells; and two standard of care patients who received no cells. All patients received standard wound care as described by the American Diabetes Association.
Twelve months post-treatment, all patients in the interim analysis who were treated with VRCs reported no major amputations, no cell-related adverse events, and healing of all open wounds.
Of the seven patients treated with normal bone marrow cells, five reported results similar to the VRC-treated patients 12 months post-treatment, one reported similar results to the VRC-treated patients 18 months post-treatment, and one patient received a major amputation. For the two standard of care patients who only received wound care (no cells), one patient received a major amputation and one patient experienced no improvement in wound healing after 12 months.
"These encouraging results indicate that VRCs are safe for therapeutic use and could offer potential advantages over the current standard of medical care in closing chronic wounds and in reducing the risk of amputation for diabetic patients with CLI," said Dr. Stratmann, who is a primary investigator in the trial along with Stanley Kirana, M.D., and Prof. Diethelm Tschope, M.D., medical director of the Center.
In a second oral presentation at the same meeting, clinical results were presented by Ulrich Noth, M.D. of the Orthopaedic Institute, Konig-Ludwig-Haus, University of Wurzburg, Germany, involving the first use of Aastrom BRCs to treat patients suffering from osteonecrosis of the femoral head.
Osteonecrosis of the femoral head involves the death of cells in the bone and marrow within the femur head and in many cases leads to total hip replacement.
Dr. Noth presented data from 4 patients. All patients tolerated the procedure well, have reported a reduction in hip pain with no signs of disease progression, as determined by MRI and X-Ray, and were back to work within 6 months after treatment. In addition, no cell-related adverse events were observed and none of these patients have required hip replacement surgery.
