An investigational cell-production system that generates therapeutic stem cells from umbilical cord blood. Indications Restoring immune and haematopoietic systems in patients without matched bone marrow donors
This trial is designed to demonstrate the ability of Aastrom CPS produced stem cells to reduce the toxicity of multi- cycle cancer chemotherapy by restoring the blood and immune system cells that are damaged or destroyed by chemotherapy and radiation therapy.
Because the Aastrom CPS may be used to produce multiple therapeutic doses of stem cells, it could facilitate various approaches in cancer therapy.
Because the Aastrom CPS is intended to produce cells used for therapy from a small starting volume, its use is expected to be less costly and invasive than alternative stem cell collection methods.
In 1993, Aastrom entered into an alliance with Cobe BCT, whereby Cobe BCT is responsible for the worldwide marketing and distribution of the Aastrom CPS for stem cell therapy applications and foreign regulatory applications and approvals.
In order to market the Aastrom CPS in Europe, the Company and Cobe BCT must obtain a CE Mark registration.
This trial is designed to demonstrate the ability of Aastrom CPS produced stem cells to reduce the toxicity of multi-cycle cancer chemotherapy by restoring the blood and immune system cells that are damaged or destroyed by chemotherapy and radiation therapy.
This trial is being conducted in Marseille, France and is the first non-clinical study of the Aastrom CPS.
Development milestones include further clinical trials in North America and Europe to assess the clinical efficacy of hematopoietic stem and progenitor cells produced by the AASTROM CPS.
Under the terms of AASTROM's 1993 agreement with COBE, COBE will exclusively provide marketing, global distribution and customer service for the AASTROM CPS for stem cell therapy applications.
These private placements should support AASTROM's core operations into late 1996, by which time the clinical value of the AASTROM CPS should be largely established,'' said AASTROM President and CEO R.
In addition, cells produced by the AASTROM CPS are inherently depleted of mature lymphocytes, making them potentially well suited for use in allogeneic (donor-to-patient) bone marrow and organ transplant procedures where immune rejection by mature lymphocytes in the graft can adversely affect the therapeutic outcome.
The AASTROM CPS should greatly simplify and facilitate access to therapeutic stem and progenitor cells by placing automated production technology for ``Ideal Transplant Cells'' in the hands of the clinical site.