Cell therapy weekly: FDA to add 50 additional reviewers, expecting 200 INDs a year by 2020

Written by RegMedNet

This week: Hematopoietic stem cell transplantation more effective against MS than existing treatments and xeno-free method produces mesenchymal progenitor cells, moving one step closer to clinical-grade bone.

The news highlights:

FDA to add 50 additional reviewers, expecting 200 INDs a year by 2020
Hematopoietic stem cell transplantation more effective against MS than existing treatments
Xeno-free method produces mesenchymal progenitor cells, moving one step closer to clinical-grade bone

FDA to add 50 additional reviewers, expecting 200 INDs a year by 2020

In a statement, FDA (USA) Commissioner Scott Gottlieb and Peter Marks, Director of the Center for Biologics Evaluation and Research, have laid out plans to deal with an expected upswing in the number of cell and gene therapies entering the approval process. By 2025, FDA predicts it will be approving 10—20 cell and gene therapy products per year and will provide an accelerated approval pathway and additional guidance documents to manage this.

“We believe these cell-based and gene therapy technologies hold tremendous promise for addressing some of the most intractable diseases……our efforts are aimed at helping innovators proactively address these potential risks, while we outline a modern and efficient pathway for the continued development of these innovations,” they explain.

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Hematopoietic stem cell transplantation more effective against MS than existing treatments

In a new study led by Northwestern University Feinberg School of Medicine (IL, USA) and published in the Journal of the American Medical Association, hematopoietic stem cell transplantation was found to be more effective against relapsing-remitting multiple sclerosis (MS) than existing disease-modifying treatments. In the study, 110 patients received the transplant along with a low dose of chemotherapy and immunosuppressants.

“I never use the word ‘cure’ — never,” said Richard K. Burt, lead author of the study and chief of Immunotherapy and Autoimmune Diseases, speaking to CNN. However, he said, only a minority of patients receiving HSCT relapse by the five year mark.

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Xeno-free method produces mesenchymal progenitor cells, moving one step closer to clinical-grade bone

New York Stem Cell Foundation (NYSCF) Research Institute (NY, USA) have developed a xeno-free method of expanding mesenchymal progenitor cells in a GMP-compatible setting. This is an important step in producing cell therapies for the treatment of blood and heart disease as well as repair damaged bone or cartilage.

“MP cells have been derived from iPSCs before, but never in a growth medium that does not contain animal-derived compounds,” commented NYSCF — Ralph Lauren Senior Investigator Giuseppe Maria de Peppo, who led the study. “We are glad to see that MP cells grown in GMP-compliant media showed the same biological and functional properties as those grown in research-grade media that contains animal products. The results will help us plan for movement of these cells out of the lab and into the clinic.”

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For more weekly cell therapy news, read previous editions of the cell therapy weekly.