Cell Therapy Archives | Page 59 of 62

Advances in in-vitro Science are Translating to Human Outcomes with Patrick Dentinger, President & CEO

March 6, 2018 By Cade Hildreth, Founder & President Leave a Comment

I had the honor of interviewing Patrick Dentinger, President and CEO of ACF Bioservices, an Absorption Systems company whose mission is to develop innovative research tools that can be used to accurately predict human outcomes. The company has facilities in Philadelphia, PA, Medford, MA, San Diego, CA, and Panama City, Panama.

In this fascinating interview, we discuss Mr. Dentinger’s background, the establishment of ACF, its origins in parent company Absorption Systems, and the critical role it is playing within the rapidly expanding cell- and gene-therapy industry. [Read more…]

Hemostemix Signs License Agreement with Aspire Health Science for ACP-01

February 25, 2018 By Cade Hildreth, Founder & President Leave a Comment

Calgary, Alberta, Feb. 23, 2018 — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce it has finalized the terms of a license agreement (the “License Agreement”) with Aspire Health Science, LLC (“Aspire”) for the Company’s lead therapeutic product technology, ACP-01. ACP-01 is currently the subject of a U.S. Food and Drug Administration (FDA) and Health Canada approved Phase II clinical trial for patients with critical limb ischemia (CLI).

Aspire is an Orlando, Florida based private company focused on the field of stem cell manufacturing as well as related research and development utilizing state-of-the-art FDA cGMP (Current Good Manufacturing Practices) certified laboratory facilities in Orlando, Florida. As previously announced, the Company also recently finalized the terms of a contract manufacturing services agreement (the “Manufacturing Agreement”) with Aspire, formalizing the transition of the Company’s stem cell manufacturing operations from Company owned facilities in Israel to Aspire’s Orlando, Florida facilities. [Read more…]

How does the U.S. FDA regulate cell therapies? (351 vs 361 Products)

February 21, 2018 By Cade Hildreth, Founder & President Leave a Comment

In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER).

According to the FDA, the Center for Biologics Evaluation and Research (CBER) regulates:

Cellular therapy products
Human gene therapy products
Certain devices related to cell and gene therapy

CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

In the U.S., human tissues intended for transplantation are regulated by the FDA as “Human cells, tissues and cellular and tissue-based products” or “HCT/Ps.” Under U.S. law, any company that engages in the collection, processing, storage, screening/testing, packaging, or distribution of HCT/Ps must register with the FDA.

[Read more…]

Cytori Completes Enrollment for Habeo™ Cell Therapy for Scleroderma and Impaired Hand Function

January 22, 2018 By Cade Hildreth, Founder & President Leave a Comment

Cytori developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs)
40 patients enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris

SAN DIEGO, Jan. 22, 2018 — Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). [Read more…]

Veritas Genetics Launches Collaboration with Mayo Clinic to Integrate Whole Genome Sequencing into Clinical Care

January 8, 2018 By Cade Hildreth, Founder & President Leave a Comment

Goal is to empower physicians and patients through making whole genome sequencing broadly available

BOSTON, Jan. 8, 2018— Veritas Genetics, The Genome Company, and Mayo Clinic are entering into an agreement to make whole genome sequencing broadly available to healthy individuals.

As part of this collaboration:

The team at Mayo Clinic’s Center for Individualized Medicine will provide medical and clinical expertise to the Veritas team.
Veritas will integrate Mayo Clinic’s know-how into its flagship product myGenome.
Patients who qualify for a Mayo Clinic research study of healthy adults will be offered Veritas myGenome screening test for whole genome sequencing.
Mayo Clinic will become a shareholder of Veritas.

“The Center for Individualized Medicine at Mayo Clinic is the gold standard in personalized medicine and we are proud and honored to collaborate with such a professional and dedicated team. This is a great step to further realize the promise of the human genome,” expressed Mirza Cifric, Founder, CEO Veritas Genetics. [Read more…]