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Home » Stem Cell News » Press Releases » Page 49

JangoBio Advancing the First Stem Cell Therapy for Hormone Restoration

December 5, 2018 By Cade Hildreth (CEO) Leave a Comment

MADISON, Wisc. – December 4, 2018 – JangoBio is making substantial progress on several commercial and scientific fronts in its quest to develop stem cell-based therapies for hormone restoration. Building on a National Institutes of Health small business grant and an initial seed investment round, JangoBio is expanding its existing animal facility and building a new headquarters in the Madison metropolitan area. The new headquarters at 2997 Yarmouth Greenway Drive (Fitchburg WI 53711) is located in the Fitchburg biotechnology research corridor and will house cell production and research laboratories along with the addition of several new employees. This new facility will complement the expansion of the existing animal laboratories on Science Drive in Madison, Wisconsin. [Read more…]

Filed Under: Press Releases Tagged With: Jango Bio

Cesca Therapeutics Receives 510(k) Clearance to Market Its AXP® II AutoXpress® Platform for Clinical Cord Blood Banking

December 4, 2018 By Cade Hildreth (CEO) 1 Comment

RANCHO CORDOVA, Calif., Nov. 19, 2018— Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its device subsidiary, ThermoGenesis® Corp., has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its proprietary AXP® II AutoXpress® Platform (AXP II) for clinical blood banking.

The AXP II, in combination with the Company’s companion, single-use, cell separation set provides automated, rapid and reliable harvest of stem and progenitor cells from collected units of umbilical cord blood in a “functionally-closed” sterile system. [Read more…]

Filed Under: Cord Blood, Press Releases Tagged With: Cesca Therapeutics, cord blood

New iPSC Lines Created for Clinical Development

December 4, 2018 By Cade Hildreth (CEO) Leave a Comment

Allele Biotech

iPSCs have been created using mRNA technologies, with cGMP control from donor screening, consenting, to skin punch, and throughout cell bank production.

iPSC production
1, iPSC colonies appear among fibroblasts; 2, isolated tight iPSC colony; 3, established iPSC 2D culture

SAN DIEGO, CA, USA, December 4, 2018 — After 3 years of cleanroom construction and 2 years of quality system establishment, Allele Biotech has produced its initial batch of 6 iPSC (induced pluripotent stem cells) lines that are ready for prime time. [Read more…]

Filed Under: iPS Cells, Press Releases Tagged With: Allele Biotechnology

Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy

November 30, 2018 By Cade Hildreth (CEO) Leave a Comment

Fate iPSC

Company to Initiate First-ever U.S. Clinical Investigation of iPSC-derived Cell Product

FT500 to be Featured in Oral Presentation on Monday, December 3 at ASH Annual Meeting

SAN DIEGO, Nov. 30, 2018  — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. [Read more…]

Filed Under: iPS Cells, Press Releases Tagged With: Fate Therapeutics

BrainStorm Cell Therapeutics Announces Submission of IND for NurOwn® in Progressive Multiple Sclerosis

November 19, 2018 By Cade Hildreth (CEO) Leave a Comment

Brainstorm

NEW YORK, Nov. 19, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 study of NurOwn® in patients with progressive multiple sclerosis (MS).

“This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease,” said Chaim Lebovits, president and CEO of BrainStorm. “This builds upon the important progress made in advancing NurOwn® in the ongoing pivotal study in ALS.” [Read more…]

Filed Under: Press Releases, Stem Cells Tagged With: Brainstorm Cell Therapeutics, multiple sclerosis

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