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Home » Stem Cell News » Press Releases » Page 56

SanBio’s Regenerative Medicine Product SB623 to Be Manufactured by Hitachi Chemical

March 13, 2018 By Cade Hildreth (CEO) Leave a Comment

March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]

Filed Under: Cell Therapy, Press Releases Tagged With: CDMO, cell therapy, SanBio

MiMedx’s AmnioFix® Injectable Awarded 15th RMAT Designation in the U.S.

March 9, 2018 By Cade Hildreth (CEO) Leave a Comment

Mimedx RMAT

MiMedx GroupIn major news released today, MiMedx Group announced that their AmnioFix® Injectable was awarded RMAT status by the U.S. FDA. This is the third RMAT designation awarded by the FDA this year and the 15th RMAT overall since the designation was introduced by the 21st Century Cures Act. The “Regenerative Medicine Advanced Therapy” (RMAT) Designation was introduced on December 13, 2016, when Congress included several provisions in the 21st Century Cures Act, an act signed into law by the 114th United States Congress authorizing $6.3 billion in funding, the bulk of which is allocated for programs supported by the National Institutes of Health (NIH).

The 21st Century Cures Act has had a profound effect on the regenerative medicine industry, supporting expansion of this industry to 600+ companies worldwide. The act also accompanies accelerated regulatory pathways that have been introduced in several other countries worldwide, including Japan, South Korea, and the E.U.

Within the U.S., sponsors of cell and gene therapies are eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs. [Read more…]

Filed Under: Cell Therapy, Press Releases, Stem Cell News Tagged With: fda, RMAT

Astellas Acquires Stem Cell Company Universal Cells for $102.5 Million

February 14, 2018 By Cade Hildreth (CEO) Leave a Comment

Astellas Pharma Acquires Universal Cells

Acquisition enables Astellas to fully utilize proprietary technology to produce pluripotent stem cells that have the potential to lower immunological rejection in numerous therapeutic areas

AstellasTOKYO, Feb. 13, 2018 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Universal Cells, Inc. (CEO: Claudia Mitchell, “Universal Cells”) today announced that Astellas has acquired Universal Cells. Astellas will gain Universal Cells’ proprietary Universal Donor Cell technology to create cell therapy products that do not require Human Leukocyte Antigen (HLA) matching, potentially overcoming a huge treatment challenge by reducing the risk of rejection.

[Read more…]

Filed Under: Press Releases, Stem Cells Tagged With: Astellas, Universal Cells

Americord Seeks Up To $6M To Fuel Its Rapidly Expanding Cord Blood Business

February 6, 2018 By Cade Hildreth (CEO) Leave a Comment

Americord Seeks $6M Funding

Americord Registry LLC Seeks Up To $6 Million In Funding To Fuel Its Rapidly Expanding Business

NEW YORK, Feb. 2, 2018 — Americord Registry LLC is seeking up to $6 million in funding to fuel its rapidly expanding business.  Ranked for the past three years as one of the fastest growing private companies in the United States, Americord intends to use the additional funds to continue its history of innovation through the development and promotion of new stem cell collection technology and innovative new stem cell therapies. [Read more…]

Filed Under: Cord Blood, Press Releases

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

January 22, 2018 By Cade Hildreth (CEO) 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…]

Filed Under: Cell Therapy, Press Releases Tagged With: cell therapy, Cytori

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