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Unicyte and Collaboration Partner Prof. Camussi Achieve Preclinical Milestone in Diabetes Program

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Unicyte, a regenerative medicine unit of Fresenius Medical Care, and its collaboration partner Professor Camussi have published results in Stem Cell Reviews and Reports that a potential therapeutic strategy for diabetes is the transplantation of induced-insulin secreting cells.

The Global Disease Burden of Diabetes Mellitus

Diabetes mellitus is one of the most common diseases globally. Diabetes mellitus (DM), commonly referred to as diabetes, is a group of metabolic disorders in which there are high blood sugar levels over a prolonged period. With an aging population and surging rates of obesity, the incidence of this debilitating disease on the rise. [Read more…]

Stem Cells for Heart Failure? BioCardia’s CardiAMP Pairs Cells, Devices and Diagnostics

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Circulation Research, the official journal of the American Heart Association, has highlighted a novel stem cell therapy approach developed by BioCardia. For those not familiar with BioCardia, the company specializes in developing regenerative biologic therapies to treat cardiovascular disease.

BioCardia has developed a stem cell technology that includes a novel method of administration, as well as a pre-procedure assay to achieve a comprehensive approach to heart failure. BioCardia’s CardiAMP and CardiALLO cell therapies are the Company’s biotherapeutic product candidates in clinical development.

In addition to providing Phase III 10-patient roll-incohort data for BioCardia’s CardiAMP device, the paper published by Circulation Research offers a comprehensive rationale of CardiAMP’s development as a treatment for heart failure. [Read more…]

Allogene Therapeutics Raises Another $120M as CAR-T Funding Frenzy Continues

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Allogene Therapeutics, a clinical-stage biotechnology company pioneering the development of allogeneic CAR T therapies for cancer, announced that it completed a $120 million private financing of Convertible Notes.

According to the company, “Allogene is advancing its allogeneic CAR T cell portfolio, which includes rights to 16 preclinical CAR T cell therapy targets and U.S. rights to UCART19, an allogeneic CAR T cell therapy candidate that is being developed for the treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is in Phase 1 development for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL).” [Read more…]

Cynata’s iPSC-derived Cell Therapeutic
(CYP-001) Meets Safety & Efficacy Endpoints

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Cynata TherapeuticsCynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs). Cynata is the only company in the world that can mass-produce therapeutic mesenchymal stem cells deriving from a single donor at a consistent quality and affordable cost. [Read more…]

FDA Awards Latest RMAT to Audentes Therapeutics for Gene Therapy Product AT132

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On August 21, 2018, Audentes Therapeutics, Inc. (Nasdaq: BOLD ) announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AT132, its treatment for X-linked Myotubular Myopathy (XLMTM).

Audentes is a biotechnology company that develops gene therapy products for patients for rare diseases.

Audentes has pursued a number of advanced regulatory pathways for AT132, including:

  • Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track and Orphan Drug designations by the FDA
  • Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA)

[Read more…]

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