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Cord Blood

Because cord blood present within a newborn’s umbilical is rich with stem cells, it can be collected and stored for future medical use.

CRISPR Therapeutics and Vertex Pharmaceuticals Win RMAT for CTX001™

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  • CRISPR Therapeutics and Vertex Pharmaceuticals Have Been Awarded an FDA RMAT Designation for CTX001™ in the Treatment of Severe Hemoglobinopathies

  • CTX001 has received Orphan Drug Designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the European Medicines Agency (EMA) for sickle cell disease and transfusion-dependent beta thalassemia

ZUG, Switzerland and Cambridge, MA, May 11, 2020 — CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. FDA RMAT designation to CTX001, an investigational, autologous, gene-edited hematopoietic stem cell therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). [Read more…]

Where Do Stem Cells Come From? Stem Cell Therapy Basics

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Where do stem cells come from? Learn the basics of these “master cells” to better understand their therapeutic potential.

With large-scale trials underway using stem cell therapeutics to address the complications of COVID-19, these cells are receiving greater clinical attention than ever before in history. Currently, the Australian stem cell company (Mesoblast) is enrolling for a 300 person trial against COVID-19 complications and the American company (Athersys) is enrolling for a 400 person trial.

If succesful, these trials could forever alter the course of the current pandemic—as well as the future of stem cell therapeutics themselves.

In this article:

  1. An Introduction to Human Stem Cells
  2. Types of Stem Cells
  3. Where Do Stem Cells Come From?
  4. The Donation Process
  5. What Can Stem Cells Treat?
  6. Stem Cells for Testing New Drugs
  7. The Benefits of Stem Cell Transplant
  8. The Survival Rate of Stem Cell Therapy

[Read more…]

TissueTech Receives RMAT from FDA for Human Umbilical Cord Product, TTAX02

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RMAT designation reinforces clinical significance of investigational biologic product TTAX02 used during in-utero fetal surgical repair of spina bifida.

MIAMI, April 16, 2020 — TissueTech, Inc., the pioneer in the development and clinical application of regenerative human birth tissue products, announced today that the U.S. Food and Drug Administration (FDA) has granted their cryopreserved human umbilical cord investigational biologic product TTAX02 RMAT designation for the treatment of spina bifida in-utero.
[Read more…]

BioStem Life Sciences Announces Launch of New Website

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Pompano Beach, FL, April 14th, 2020 — BioStem Life Sciences, a wholly owned subsidiary of BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem” or the “Company”), and a certified full-service GMP contract development and manufacturing organization, with a focus in perinatal tissue-based medical products, today announced that it had launched a new website at www.BioStemLifeSciences.com. [Read more…]

COVID-19 Diagnostic Kits: Total Number, Types and Speed

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As of today, 41 laboratory COVID-19 diagnostic tests have been authorized by regulators to identify the virus. In the U.S., these tests are supplied by the CDC for the state and local public health departments and private medical providers are getting tests developed by the commercial manufacturers. The U.S. government did not issue guidance allowing commercial labs to process COVID-19 tests until February 29, 2020, after which the companies began testing within a week.

Currently, 20 COVID-19 diagnostic kits from the U.S. manufacturers have won the emergency use authorization (EUA) from the FDA. [Read more…]

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