Treatment for multiple sclerosis (MS) is an evolving area and one in which new therapeutic approaches are rapidly advancing. Led by Dr. Saud Sadiq, the Tisch MS Research Center of New York is pursuing a Phase II clinical trial exploring the use of stem cell technology for the treatment for MS. The announcement followed positive results from an FDA-approved Phase I stem cell trial for MS. [Read more…]
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FDA Regulation of Cellular and Tissue-Based Products with Dr. Riam Shammaa
In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products.
While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of cell therapy, gene therapy, and tissue engineering products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.
Dr. Robert Hariri – Placental Pioneer Launches Celularity with $250M Cash

Dr. Robert Hariri is a fascinating figure in the stem cell industry, because he was the earliest pioneer to recognize the regenerative potential of the human placenta. In August 2017, Hariri brought his latest company, Celularity, into the spotlight by announcing a successful Series A financing with contributions from influential investors, including United Therapeutics Corporation, Celgene, Sorrento Therapeutics, and Human Longevity, Inc. (HLI).
Today, Celularity’s investor contributions have reached an astounding $250 million, including contributions from the Genting Group, Dreyfus Family Office and Tony Robbins, among other notable investors. [Read more…]
How Celularity is Leading the Next Evolution in Cellular Medicine
Celularity is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases.
Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity is uniquely positioned to harness the potential of most biocreative event on earth: human birth. [Read more…]
Gamida Cell, President Dr. Yael Margolin Reveals the Unmet Need in HSCT

Gamida Cell is a cell therapy company that is best known for its innovative approaches to hematopoietic stem cell transplantation (HSCT). Headquartered in Jerusalem, Israel, Gamida Cell has been advancing several clinical programs using ex vivo expanded hematopoietic stem cells (HSCs) created using its proprietary nicotinamide (NAM) technology.
I had the honor of interviewing Dr. Yael Margolin, President of Gamida Cell. In this interview, we discuss how Gamida Cell is using cell therapeutics to address the unmet need in hematopoietic stem cell transplantation (HSCT). [Read more…]
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