Cell therapy weekly: Implantable reservoir of cells could help treat heart attack damage

Written by RegMedNet

This week: Traumatic brain injury therapy receives funding and Holoclar® comes to the USA.

The news highlights:

Implantable reservoir device will allow controlled release of drugs, stem cells
DoD contract will support stem cell research for severe traumatic brain injury
Holoclar® receives Orphan Drug Designation

Implantable reservoir device will allow controlled release of drugs, stem cells

A team of researchers from Massachusetts Institute of Technology (MIT; MA, USA), Harvard University (MA, USA), Royal College of Surgeons in Ireland (Dublin, Ireland), Trinity College Dublin (Dublin, Ireland), Advanced Materials and BioEngineering Research Center (Dublin, Ireland), and National University of Ireland Galway (Galway, Ireland) have developed a device in which a reservoir of therapeutic agent is attached directly to the skin. ‘Therepi’ is ideal for administering cell therapies, where it behaves like a cell factory, allowing paracrine factors from the cells to pass into damaged tissue whilst holding the cells safe.

“After a heart attack we could use this device to deliver therapy to prevent a patient from getting heart failure,” explained Ellen Roche, co-first author of the study and assistant professor at MIT’s Department of Mechanical Engineering and Institute for Medical Engineering and Science. “If the patient already has some degree of heart failure, we can use the device to attenuate the progression.”

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DoD contract will support stem cell research for severe traumatic brain injury

Neuralstem, Inc. (MD, USA) has received a US$150,000 Phase I Small Business Innovation Research contract by the Department of Defense (DoD; VA, USA) to support development of NSI-566, a human neural stem cell line that has been shown to confer neurological improvement in some indications upon transplantation. The award will focus on the development of NSI-566 as a candidate for severe Traumatic Brain Injury (TBI) and it is hoped the research will culminate in the filing of an Investigational New Drug application to allow the commencement of clinical trials.

“We are very pleased and appreciative that the DoD has chosen to fund this project,” commented Rich Daly, President and CEO of Neuralstem. “Severe TBI represents a significant unmet medical need, and we are excited to continue our preclinical studies to establish the therapeutic potential of neural stem cells in this indication.”

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Holoclar® receives Orphan Drug Designation

GPLSCD01, an ex-vivo expanded autologous human corneal epithelial cell-based therapy developed Holostem Terapie Avanzate S.r.l. (Modena, Italy) and commercialized by Chiesi USA (NC, USA), has been granted Orphan Drug Designation by the FDA. GPLSCD01, known as Holoclar® in Europe, has been developed to treat limbal stem cell deficiency (LSCD), a rare and debilitating condition that can result in chronic pain, burning, photophobia or complete loss of vision, amongst other symptoms. GPLSCD01 consists of a cell sheet of epithelium cultured from undamaged limbus that is transplanted.

“We are very pleased to receive orphan drug designation for GPLSCD01 for patients with LSCD. This is an important regulatory milestone for Chiesi USA as we continue to focus on meeting the needs of the rare disease community,” said Alan Roberts, Vice President of Scientific Affairs, Chiesi USA. “Once FDA-approved, GPLSCD01 has the potential to become an important medical therapy for LSCD patients in the U.S.”

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