Donorsĭonors were selected after rigorous testing according to federal regulation 21 CFR1271 regarding allogeneic cell products. All patients were not allergic to penicillin or ciprofloxacin. Additionally, local IRB approval for the general protocols and procedures is in place. All patients have been accepted by an independent medical review board deeming that the patients have failed all standard treatment options. A detailed description of the therapeutic effects and rationale for use in the indications described will be provided in subsequent publications.įour patients were treated as part of a compassionate use, physician initiated program. In this short report we detail expansion, quality control, and initial safety data from patients treated under compassionate use in a physician-initiated setting. We have previously demonstrated karyotypical stability up to 68 doublings, as well as lack of tumor formation ability or tumor acceleration in animal models. Given the general clinical safety profile of MSC from other sources, we conducted initial studies to determine the safety profile of ERC. Neuronyx is currently performing Phase I clinical trials using allogeneic human adult bone marrow-derived somatic cells ( hABM-SC) for post infarct healing. Angioblast Systems has recently announced initiation of Phase II trials using Mesenchymal Precursor Cells™ for stimulation of cardiac angiogenesis. Athersys is currently in Phase I trials using its MultiStem™ technology, which involves ex vivo expanded multipotent adult progenitor cells (MAPC) for post-infarct heart repair. Other companies have entered clinical trials using allogeneic MSC-based products. Intravenous administration of allogeneic MSCs by Osiris was also reported to induce a statistically significant improvement of cardiac function of MI patients in a double-blind study. The company Osiris Therapeutics has successfully completed Phase I safety studies using allogeneic MSCs and has currently ongoing Phase II and Phase III trials for Type I Diabetes, Crohn's Disease, and Graft Versus Host Disease using allogeneic bone marrow derived MSC. Allogeneic bone marrow derived MSC have been used by academic investigators for treatment of diseases such as graft versus host (GVHD), osteogenesis imperfecta, Hurler syndrome, metachromatic leukodystrophy, and acceleration of hematopoietic stem cell engraftment with clinical benefit. For example, cord blood derived MSC have also demonstrated benefit in a patients with critical limb ischemia caused by Buerger's Disease. In animal models, acceleration of wound healing, or post-infarct recovery, has been accomplished by administration of allogeneic mesenchymal cells.Īllogeneic MSC therapy is a clinical reality. The use of allogeneic cells as a therapeutic approach in immune competent recipients has previously been performed with bone marrow derived mesenchymal stem cells (MSC) which are known to inhibit ongoing mixed lymphocyte reaction (MLR), induce generation of T regulatory cells, and suppress autoimmunity in vivo in conditions such as collagen induced arthritis and experimental allergic encephalomyelitis. Thus theoretically ERC may be useful as an allogeneic 'off-the-shelf' therapy. In vivo ERC appear to induce therapeutic effects in immune competent xenogeneic recipients. Immunological characterization of ERC revealed hypoimmunogenicity when used as stimulators in mixed lymphocyte reaction, as well as active suppression of proliferating T cells in vitro. Phenotypically ERC appear to share some markers with mesenchymal stem cells such as CD90 and CD105 but are unique in that they express hTERT and OCT-4. Endometrial Regenerative Cells (ERC) are a population of plastic adherent, mesenchymal-like stem cells that are possess in vitro pluripotency, and in vivo therapeutic activity in models of limb ischemia and infarcts.

Garnet neuronyx