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Cell therapy weekly: Vital Therapies abandons liver cell therapy, loses 80% share price

This week in cell therapy: Cell and Gene Therapy Catapult is granted MHRA manufacturing licenses and baby teeth stem cells shown to regrow damaged dental tissue.

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Sep 13, 2018
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The news highlights:

Liver cell therapy scrapped after failing to achieve Phase III endpoints
Cell and Gene Therapy Catapult is granted new licenses for commercial production of cell and gene therapies
Baby teeth stem cells shown to regrow damaged dental tissue

Liver cell therapy scrapped after failing to achieve Phase III endpoints

Shares in Vital Therapies, Inc. (CA, USA) have slid more than 80% following news their proprietary cell-based therapy for acute liver failure, ELAD®, failed to meet its primary and secondary endpoints of improval in survival. Vital Therapies is currently exploring strategic options as the ELAD System was its only product in development.

“Although we did not achieve the outcome we were hoping for, we would like to thank those who made this trial possible, including our investigators and their staffs, the patients who were enrolled and their families, and all Vital Therapies employees,” said Russell J. Cox, the Company’s Chief Executive Officer.

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Cell and Gene Therapy Catapult is granted new licenses for commercial production of cell and gene therapies

The Medicines and Healthcare products Regulatory Agency has granted the Cell and Gene Therapy Catapult’s Stevenage center a Manufacturing and Importation Authorization (MIA) and an MIA for investigational medicinal product (MIA IMP), an EU requirement for facilities producing commercial medicines for use in clinical trials or clinical application. Current companies developing their manufacturing and supply systems at the Centre include Autolus, Cell Medica, Adaptimmune and Freeline, and the center is already being expanded to meet demand.

“The granting of these licenses…demonstrates how our Stevenage manufacturing center is becoming one of the world’s leading facilities for the development and production of cell and gene therapies. We now look forward to working with our current collaborators as they leverage our licenses to move towards production of the first batches of clinical materials,” commented Keith Thompson, CEO, Cell and Gene Therapy Catapult.

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Baby teeth stem cells shown to regrow damaged dental tissue

Human deciduous pulp stem cells (hDPSC) extracted from baby teeth have been shown to regrow dental pulp in a Phase I trial of 40 children. For 30 children receiving the experimental treatment, hDPSCs were extracted, expanded in vitro and implanted back into an injured tooth. Follow-up demonstrated more signs of healthy root development and thicker dentin in the cohort receiving the hDSC treatment compared with the control cohort, who receive apexification.

“This treatment gives patients sensation back in their teeth. If you give them a warm or cold stimulation, they can feel it; they have living teeth again,” explained Songtao Shi, professor and chair in the Department of Anatomy and Cell Biology in Penn’s School of Dental Medicine (PA, USA). “So far we have follow-up data for two, two and a half, even three years, and have shown it’s a safe and effective therapy.”

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

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