Cell therapy weekly: FDA issues statement marking halfway point in enforcement period for unproven regenerative medicine therapies

This week: Editas and BlueRock combine proprietary technology to develop engineered cell therapies and tissue-softening enzyme supports corneal regeneration.

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Apr 04, 2019
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The news highlights:

FDA issues statement marking halfway point in enforcement period for unproven regenerative medicine therapies
Tissue-softening enzyme supports corneal regeneration
Editas and BlueRock combine proprietary technology to develop engineered cell therapies

FDA issues statement marking halfway point in enforcement period for unproven regenerative medicine therapies

FDA Commissioner Scott Gottlieb and Biologics Center Director Peter Marks have released a statement reiterating the Agency’s commitment to tackling purveyors of unproven stem cell and regenerative medicine therapies. The statement comes halfway through the enforcement period during which these ‘bad actors’, as they are often referred to by FDA, are required to comply with FDA regulations or face repercussions.

“There’s no room for companies that place patients at risk through products that violate the statutes and our regulations, including by not having in place an IND or biologics license,” Gottlieb and Marks explained in their statement, whilst also commending the investigators who are doing “essential groundwork” in examining the safety and potential benefits of investigational therapies.

Read the full statement

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Tissue-softening enzyme supports corneal regeneration

Researchers from Newcastle University (Newcastle, UK) have found that softening the stem cell niche maintains the stemness of corneal stem cells, maintaining their ability to self-renew and heal wounds. In the work, a formulation containing the enzyme collagenase, which has already been approved for therapeutic applications by FDA, was applied locally to stiffened areas of corneal tissue, damaged after chemical burns.  

Study director Professor Che Connon commented: “Our research shows that corneal stem cells grow better in softer environments. We now want to build on that knowledge and test this method in patients, using biomechanical modulation therapy to re-create suitable environments for corneal stem cells to thrive within the body whenever their original niche is compromised by injury or disease.”

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Editas and BlueRock combine proprietary technology to develop engineered cell therapies

In a new strategic collaboration, Editas Medicine and BlueRock Therapeutics (both MA, USA) will combine their respective gene editing and cell therapy technologies to develop engineered cell therapies for oncology, neurology, cardiology and immunology. Editas’ CRISPR technology will be applied to BlueRock’s iPSC platform to develop engineered, differentiated therapies that can be used ‘off the shelf’.

“We believe combining CRISPR-based genome editing with cell therapy has the potential to deliver game-changing allogeneic medicines, and we are excited to work with the team at BlueRock to develop genome-edited iPSCs with the potential to enable and accelerate the development of numerous, transformative medicines for people with many serious diseases,” said Cindy Collins, Interim Chief Executive Officer, Editas Medicine.

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

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