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Cleveland researchers collaborate to launch Phase 1 clinical trial for new MS treatment
Date:8/23/2011

ulti-institutional program comprised of investigators from Cleveland Clinic, Case Western Reserve University, UH Case Medical Center, Athersys, Inc., and the Ohio State University.

The research process will involve:

  • Baseline testing, including general and neurologic exams, vision testing, MRI, and optical coherence tomography, conducted at Cleveland Clinic's Mellen Center.
  • Participants have their bone marrow aspirated from their hip in the Coleman Clinical Research Suite at UH Case Medical Center.
  • The stem cells will be culture-expanded in the CTL in the NCRM then frozen.
  • Participants then have their stem cells infused in the Mellen Center.
  • Follow-up monitoring and testing will be done at the Mellen Center.

Dr. Cohen's study utilizes the CTL based in the Case Western Reserve University School of Medicine NCRM, which is the only academic cleanroom facility for cellular therapy procedures in Northeast Ohio. The role of the CTL is to culture expand or "manufacture" the human MSCs for reinfusion into study subjects.

This study requires a specialized Class 10,000 cleanroom environment and uniquely qualified personnel because the study subject's marrow cells need to be grown ex vivo (outside of the body) for approximately a month to achieve an adequate number of MSCs. Once the desired dose is obtained, the cells are tested extensively to confirm they are viable and not contaminated to ensure safety, then cryopreserved. At a later date, they are transported to Mellen Center, carefully thawed, and infused intravenously. This type of cell manipulation is performed under the authority of the US Food and Drug Administration and must follow strict procedures, documentation, environmental and equipment monitoring, and quality assurance that is not feasible in a typical research lab.

The bone marrow harvesting is performed by physicians in the Coleman Clinical Research Suite in the UH Seidman Cancer Cent
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Contact: George Stamatis
george.stamatis@uhhospitals.org
216-844-3667
University Hospitals Case Medical Center
Source:Eurekalert

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