First US clinical trial for transplant virus cell therapy and first patients treated in clinical trial of degenerative disc disease cell therapy
The news highlights:
The International Society for Cell and Gene Therapy (ISCT, BC, Canada) — global drivers of cell therapy translation and patient access — has released warning advice to patients concerning so-called T-cell preservation . The controversial process leverages the benefits of CAR-T cell immunotherapies to promote third party cryopreservation services to enable storage of T-cells for future use. Such services are marketed to individuals of the public who consider themselves at risk of potentially requiring therapeutic treatment with CAR-T cell therapies in the future. The ISCT has spearheaded objection towards such unproven, unethical techniques.
Massimo Dominici, Chair of the ISCT Presidential Task Force on the Use of Unproven and/or Unethical Cell & Gene Therapy, commented: “Patients and members of the public need to have the right information available to make informed decisions on using services to preserve healthy T-cells…Without scientific validation, these companies are creating the ground for “frozen” unproven cell and gene therapies, potentially generating disappointing and even harmful results for the field.”
The University of Wisconsin’s Program for Advanced Cell Therapy (PACT; WI, USA) is to carry out the first, FDA-approved clinical trial of a novel cell therapy for cytomegalovirus (CMV) infection; this is contracted by up to 40% of kidney and pancreas transplant recipients. The study will explore the use of virus-specific white blood cells — engineered white blood cells harvested from patients or close relatives that effectively recognize and kill virus cells — for treating CMV infection. In transplant recipients, who are often immunosuppressed, CMV infection can be fatal.
Jacques Galipeau, Director of PACT, commented: “The use of living cells collected from relatives with intact immunity to cure viral complications of transplantation is an entirely new therapy for a vexing problem.”
DiscGenics (UT, USA), a biotechnology company that specializes in clinical-stage, pain-relieving cell therapies for degenerative disc disease (DDD), has announced the first results of their Japanese clinical trial program. The ongoing trial is investigating the efficacy of IDCT — an injectable, allogeneic, cell-based therapy comprising engineered Discogenic Cells derived from intervertebral disc tissue — in patients with mild to moderate DDD.
Flagg Flanagan, CEO and Chairman of the DiscGenics Board of Directors, commented: “Commencing clinical evaluation of our first product candidate in Japan is a significant milestone for DiscGenics as we continue to advance IDCT as a potentially revolutionary treatment for DDD…With IDCT, we have an opportunity to serve Japan’s aging population by providing a novel, interventional therapy for DDD, one of the most common causes of chronic low back pain and a well-known unmet medical need.”
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