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Habeo Cell Therapy by Cytori Therapeutics

ADRC Stem Cell Therapy for Diffuse Scleroderma Hand Involvement

Jo FrowdeHello, I am Jo Frowde, ISN Guide to Habeo Cell Therapy. Habeo Cell Therapy by Cytori Therapeutics is an experimental treatment in clinical trial for diffuse scleroderma hand involvement. See Disclaimer.

Tree PaintingHabeo Cell Therapy by Cytori Therapeutics is an experimental treatment in clinical trial for scleroderma hand involvement. It entails removing fat cells from the patient, harvesting the stem cells, and reintroducing them. The Phase III trials showed some benefit, particularly for hand involvement in diffuse cutaneous scleroderma patients who have sclerodactyly (hands hardened by scleroderma.) (Also see: What is Scleroderma?, Diffuse Scleroderma, and Sclerodactyly)

Cytori Scleroderma Trial Data Presented at Systemic Sclerosis World Congress. Cytori Therapeutics, Inc. presented data from the U.S. 88 patient, 19 center, randomized, double blind, placebo-controlled STAR clinical trial of Cytori Cell Therapy™ (Habeo™) for the treatment of impaired hand function in patients with systemic sclerosis (SSc). Globe Newswire, 02/15/2018.

American Medical Association Adding Cytori’s Cell–Based Therapy for Scleroderma Hand Problems to Key Database. The American Medical Association is adding descriptions of Cytori Therapeutics’ cell–based therapy for scleroderma of the hands to its authoritative database of medical procedures, services and technology. Scleroderma News, 07/11/2017.

Cytori Logs Final 48 Week Patient Follow Up Visit in Scleroderma Trial. Cytori Therapeutics, Inc. today announced that it has now completed all 48 week follow up monitoring visits in its U.S. FDA approved Phase III STAR trial. A total of 88 subjects were enrolled and the last subject’s 48 week visit was conducted earlier this week. Globe Newswire, 05/23/2017.

Cytori’s Managed Access Program. Cytori’s Managed Access Program in select countries across Europe, the Middle East, and Africa is intended to provide patients with hand impairment due to scleroderma early access to ECCS-50 therapy. Cytori Theraputics Inc.

Cytori Presents Scleroderma Clinical Trial Data at the 2016 American College of Rheumatology Annual Meeting. Cytori Therapeutics, Inc. present data from its STAR Phase 3 clinical trial describing progress, preliminary blinded patient characteristics, and safety of adipose–derived regenerative cells (ADRCs) for treatment of scleroderma hand dysfunction at the Annual Meeting of the American College of Rheumatology on November 15, 2016. Business Wire, 10/26/2016.

Cytori Therapeutics Completes Patient Enrollment in Phase 3 STAR Trial for Scleroderma Cytori Therapeutics recently announced that its FDA-approved Phase 3 STAR clinical trial evaluating ECCS-50 has enrolled and treated its 80th patient, reaching 100 percent of its target enrollment. Scleroderma News, 05/31/2016.

Cytori Granted SME Status by European Medicines Agency The European Medicines Agency's (EMA) Micro, Small and Medium-sized Enterprise (SME) office has granted SME status to Cytori Therapeutics. Business Wire, 03/23/2016.

First Patient Treated in the U.S. STAR Trial. Cytori has successfully begun its first ever U.S. approval trial and consistent with their experience in treating scleroderma in Europe, the patient tolerated the procedure well. Cytori, 08/25/2015.

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR). The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma. ClinicalTrials.gov, 08/24/2015.

FDA Approves Cytori U.S. Pivotal Scleroderma Trial. The STAR trial will begin enrolling in 2015 and will include 80 patients, in up to 12 centers in the United States. The trial is a randomized, double-blind, placebo-controlled study of the safety and efficacy of a single administration of Cytori's lead cellular therapeutic, ECCS-50, in scleroderma patients with hand dysfunction. MarketWatch, 01/12/2015.

Completed Study. Positive Results. France Only

Cytori Therapeutics Receives Approval for Scleroderma Study in France. Per the study protocol, 13 patients will receive an injection of their own adipose-derived stem and regenerative cells (ADRCs) into the affected areas of their fingers. StreetInsider.

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