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TOPIC: And a presentation of Scleradec in Japan

And a presentation of Scleradec in Japan 17 May 2016 07:34 #7030

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SAN DIEGO & TOKYO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that on May 18, 2016, an update regarding the French SCLERADEC I and II clinical trials investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction will be delivered at the 104th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan.
Professor Guy Magalon, the SCLERADEC-I principal investigator, is scheduled to present, “New Strategy and Possibility for Using ADRCs for Treating Scleroderma,” in the International Invited Lecture session on May 18th at the ANA Intercontinental Tokyo in Room A from 10:45 to 11:45 am.
Scleroderma has been designated as an intractable disease in Japan, estimated to affect 27,800 people.† A study from Japan in 1991 shows that a high number of these patients have hand symptoms. Specifically, 98% exhibit Sclerodactyly (thickening and tightness of the skin in fingers, often leading to ulceration of the fingers) and 95% exhibit Raynaud’s Phenomenon.‡ Pre-clinical and clinical studies suggest that adipose-derived regenerative cells, or ADRCs, may promote angiogenesis, modulate inflammation and reduce/remodel fibrosis. In addition, Dr. Magalon reported that the open-label SCLERADEC I trial showed a sustained benefit over a two-year period using ADRC therapy prepared by Cytori’s Celution® System. Dr. Magalon will detail those findings in Japan at this presentation.
“Hand involvement is common in scleroderma and few effective medical options exist,” said John Harris, Vice President and General Manager, Cell Therapy. “We are very grateful that Dr. Magalon is here in Japan highlighting the results of this seminal work. The timing coincides nicely with our development and partnering plans here in Japan that have the goal of bringing Cytori’s novel ECCS-50 therapy for hand scleroderma to the market.”
Cytori’s U.S. FDA approved Phase III STAR trial is currently enrolling and thus far, is 75% of the way toward complete enrollment. The trial is scheduled to complete enrollment by mid-June, which is ahead of original schedule. The STAR trial follows the French SCLERADEC-I pilot trial, led by Drs. Magalon and Granel, which was performed at the Assistance Publique Hôpitaux de Marseille. One year post-treatment results were published in the August 2015 edition of the journal Rheumatology. Data recently presented at the Systemic Sclerosis World Congress indicated that a single administration of ECCS-50 therapy could be performed safely and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through 2 years following treatment.
† Japan Ministry of Health, Labor and Welfare
‡ Tamaki T, Mori S, Takehara K. “Epidemiologic study of patients with systemic sclerosis in Tokyo.” Arch Dermatol Res 1991;283(6):366 –71.
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

And a presentation of Scleradec in Japan 17 May 2016 08:17 #7031

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US Stem Cell Treating Patients in U.S. (Formerly Bioheart)

Join us for journal club and partake in a discussion with Kristin Comella as she reviews a recently published article, "Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up."

When: Tuesday, May 24th, 2016
Time: 12:00 PM EDT



Impaired hand function greatly contributes to disability and reduced quality of life in SSc patients. Autologous adipose-derived stromal vascular fraction (ADSVF) is recognized as an easily accessible source of regenerative cells. We reported positive 6-month safety and efficacy results from an open-label clinical trial assessing s.c. injection of autologous ADSVF into the fingers in SSc patients. The objective of this report is to describe the effects at 12 months.

Methods. Twelve females, mean age 54.5 years (S.D. 10.3), were assessed 1 year after ADSVF injection. Patients were eligible if they had a Cochin Hand Function Scale score >20/90. ADSVF was obtained from lipoaspirate using an automated processing system and subsequently injected into the s.c. tissue of each finger in contact with neurovascular pedicles in a one-time procedure. Endpoints were changes in hand disability and skin fibrosis, vascular manifestations, pain and quality of life at the 12 month follow-up. During the visit, patients estimated the benefit of the procedure with a specific self-completed questionnaire.

Results. A significant decrease from baseline of 51.3% (P < 0.001) for Cochin Hand Function Scale score, 63.2% (P < 0.001) for RP severity and 46.8% (P = 0.001) for quality of life (Scleroderma Health Assessment Questionnaire) was observed. A significant improvement of finger oedema, skin sclerosis, motion and strength of the hands and of the vascular suppression score was also noted. The reduction in hand pain approached statistical significance (P = 0.052). The questionnaire revealed a benefit in daily activities, housework and social activities.

Conclusion. ADSVF injection is a promising therapy and appears to have benefits that extend for at least 1 year.


Ms. Comella is a world renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapin's list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Ms. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose. She led the team that gained the first ever FDA approval for a clinical trial using a combined cell and gene therapy product in the heart. In addition to advanced cell culturing experience, Ms. Comella's repertoire includes managing the development, manufacturing, and quality systems of cellular products. She has developed a wide range of regenerative techniques and products that have now been successfully implemented into the clinic setting. She is currently serving as the Chief Scientific Officer and board member of US Stem Cell, a publically traded company focusing on the discovery, development, and commercialization of autologous cell therapies for the treatment of degenerative diseases.

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