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BioInformant's coverage of stem cell news includes iPS cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells and more.

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I Peace, Inc. Introduces Clinical-Grade iPS Cell Custom Manufacturing Service

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PALO ALTO, Calif., May 15, 2020 — I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-wining technology “induced pluripotent stem cell (iPSC)” began manufacturing clinical-grade iPSCs. We are now officially taking orders for custom manufacturing of clinical-grade iPSCs from institutions around the world.

On March 11, 2020, the company received a license to manufacture clinical-grade cells from Japan’s Ministry of Health, Labour and Welfare for its cell manufacturing facility located in Kyoto, Japan. [Read more…]

FDA Approves Two Emergency INDs to Administer Organicell Flow for COVID-19

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First Patients treated with Organicell Flow through “Emergency Single Patient Compassionate Use” designation

MIAMI, May 19, 2020 — Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that on May 11, 2020, the U.S. Food and Drug Administration (FDA) authorized two Emergency Compassionate Use Investigational New Drug applications (eINDs), each for a single patient severely ill from COVID-19. These critical patients have received immediate administration of Organicell Flow. [Read more…]

What Is An RMAT? List of RMAT Designations (44)

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To date, 44 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 139 requests and issued 48.

Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.

The most recent addition to this list was the RMAT jointly awarded to CRISPR Therapeutics and Vertex Pharmaceuticals for CTX001™ in the treatment of severe hemoglobinopathies.

Prior to that, it was Immunicum’s ilixadencel on May 6, 2020. Ilixadencel consists of activated allogeneic dendritic cells used as an immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC).

[Read more…]

Mesoblast to Enroll 300 Patients in COVID-19 Trial of Stem Cell Therapy Remestemcel-L

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Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment

NEW YORK, April 30, 2020 — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment. [Read more…]

Stem Cells for Coronavirus: Could Cells Be The Cure?

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*Article Updated 05/06/20 — Coronavirus disease (COVID-19) is an emerging global pandemic that is threatening the viability of healthcare systems worldwide. The virus responsible for the disease is also known as severe acute respiratory syndrome coronavirus 2 and abbreviated as SARS-CoV-2. The eruption started in China on December 29, 2019 and by March 2020 it was reported that it had spread to several countries across the world. [Read more…]

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