Cision PR Newswire
CELL Announces The Award of a No Objection Letter from Health Canada And The Approval of The First Ever Pivotal Stem Cell Clinical Program for Pain in The World
News provided byCell Technologies Inc.
Sep 18, 2023, 8:05 AM ET
TORONTO, Sept. 18, 2023 /PRNewswire/ - CELL Technologies Inc. is pleased to announce the award of a No Objection Letter (NOL) from Health Canada to launch the first ever pivotal stem cell program in pain and Osteoarthritis in the world.
"I want to congratulate all Canadians. To have the first approved pivotal stem cell program in the world being launched in Canada, is a huge victory for all of us," says CEO Dr. Riam Shammaa.
"Now patients across Canada have access to evidence-based and regulatory validated stem cells," says Dr. Shammaa.
"I want to thank the team of CELL for their great work and dedication over the years to get to this huge success," says Shammaa.
The program now allows patients with pain conditions to enroll in evidence-based and regulatory validated stem cell treatment across all Canada.
"The No Objection Letter is a significant seal of approval from Health Canada," says Dr. Gregory Murphy, Chief Medical Officer of CELL.
"It means that the regulators have reviewed and approved the efficacy of our scientific and clinical data. It also means that the regulators have reviewed and validated the safety of our processing and manufacturing, and they green light enrolling patients in the first evidence-based stem cell pivotal program in the world," says Dr. Murphy.
Based on the breakthrough data and the positive regulatory approval, CELL is now preparing to file with the FDA to get a similar approval in the US.
CELL is a clinical stage biotech company pioneering stem cell therapy in pain medicine and inflammatory conditions, CELL's platform is based on proprietary technology in both autologous and allogeneic programs with more than 10 years of research in the field of cell therapy.
CELL is the leader in stem cell therapy in North America and aims to become the first provider of stem cells for regenerative medicine globally.
For information and for patients looking to access the stem cell program: firstname.lastname@example.org
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SOURCE Cell Technologies Inc.
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