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TOPIC: Scleroderma Therapy Benefit Sustained at 1 Year

Scleroderma Therapy Benefit Sustained at 1 Year 10 Sep 2015 06:05 #5189

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) announced the publication today of the results from the 12 month clinical follow up of patients enrolled in the Scleradec-I clinical trial from hand dysfunction common in patients with the rare disease scleroderma. The Scleradec-I trial, an investigator-initiated, open-label 12 patient trial, was led by Dr. Brigitte Granel and Dr. Guy Magalon from the Assistance Publique des Hôpitaux de Marseille. The manuscript was published in the journal Rheumatology [ rheumatology.oxfordjournals.org/content/early/2015/09/08/rheumatology.kev323.abstract ].

The publication documented that a single treatment with Cytori Cell Therapy™, known as ECCS-50, provided prolonged improvements in patients with impaired hand function due to scleroderma. Specifically, hand function assessed using the validated clinical measure known as the Cochin Hand Function Scale and overall health status using the Scleroderma Health Activity Questionnaire improved from baseline by an average of 51.3% and 46.8%, respectively, at 12 months (p=0.001 for both). Raynaud’s Condition Score, which measures the incidence and severity of Raynaud’s phenomena, was reduced by 63.2% from baseline at 12 months (p<0.001). Other key findings include a 30.5% improvement from baseline in grip strength (p=0.002) and 34.5% improvement from baseline in pain (p=0.052).

Relative to the data measured in these patients at 6 months after treatment, the 12 month data included evidence of on-going benefit across a number of endpoints. For example, fibrosis of the hand, an important pathophysiologic feature of the disease, was assessed using the modified Rodnan Skin Score and declined by 22.9% relative to baseline (p=0.014). Similarly, capillaroscopic assessment of vascular suppression improved by 35% compared to baseline (p=0.001).

The follow on European Phase III trial known as Scleradec II is a larger, randomized, controlled trial designed to substantiate these findings and is anticipated to begin before the end of the year.

Based in part on the preliminary 6 month data from this study, Cytori has received FDA IDE approval for the STAR trial, a pivotal (Phase III) clinical trial of Cytori Cell therapy for the treatment of hand dysfunction and Raynaud’s phenomena in patients with scleroderma. This 80 patient, multi-center, randomized, double-blind placebo-controlled trial began enrolling in August of 2015.

“The observation that the improvement in hand function and Raynaud’s phenomena that was seen at 6 months, persists to at least 12 months with a single administration of Cytori Cell Therapy should provide added optimism on the outlook of this therapy for patients and their families,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics. “The prolonged benefit across a number of concordant endpoints in these patients is very encouraging. The recent start of the STAR trial brings us a step closer to understanding what role Cytori Cell Therapy may have in scleroderma.”

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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:

Scleroderma Therapy Benefit Sustained at 1 Year 10 Sep 2015 06:09 #5190

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Text Abstract linked in announcement:

Autologous adipose-derived stromal vascular fraction in patients with systemic sclerosis: 12-month follow-up
Submitted 15 December 2014 revised version accepted 4 August 2015

Abstract

Objective. 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.

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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:
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