Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

NCT01813279 | Completed DMC

• 2 other identifiers: 2011-A01228-332011-28
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are excessive severity of the disease. This condition can affect the hands with a major functional consequence severely impairing the quality of life of patients. Adipose tissue is used in plastic surgery for over a century for the filling of depressions in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue was noted. It is shown that the stromal vascular fraction is responsible for this regenerative effect. In a previous study the investigators have demonstrated in a mouse model that the subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the fibrosis of the dermis and providing a pro angiogenic. Objectives and means: This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands. Eleven patients with scleroderma with the hands will be included in the study. Due to the nature of the orphan disease, a longitudinal study be conducted, where each patient will have own control. The evaluation will be pre and post operative for a period of six months. This evaluation will be based on clinical criteria (trophic balance, functional) and laboratory (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue). Project schedule and implementation phases: The project will run over a period of twelve months. Patients will be followed for a period of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved over a period of six months. Expected Results: This study will validate the functional and trophic effects of reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma. Conclusion: This innovative cell therapy could represent an alternative treatment for patients with scleroderma in check, intolerant or insufficiently relieved by medical treatment currently available in the scleroderma hand

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• The improvement of the functional index of Cochin

  2 years

Secondary Outcomes (5)

• Analog visual scale ( EVA )

  24 MONTHS

• Evaluation of the severity of the syndrome of Raynaud

  24 months

• The test HAMIS

  24 months

• The score of Rodnan modified in the hand

  24 months

• -The test HAMIS

  24 months

Study Arms (1)

patients

EXPERIMENTAL

Other: the cell therapy

Interventions

the cell therapy OTHER

the reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of more than 18 years old wishing a therapeutic alternative.
• Functional Disability of the hand authenticated by a functional index of the hand of Cochin upper to 20.

You may not qualify if:

• Persons participating simultaneously in another biomedical search(research)
• Minors
• Pregnant or breast-feeding Women
• Major Persons protected by the law (under guardianship or guardianship)
• Persons staying in a sanitary or social establishment
• Persons in emergency situation
• Private persons of freedom

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Granel B, Daumas A, Jouve E, Harle JR, Nguyen PS, Chabannon C, Colavolpe N, Reynier JC, Truillet R, Mallet S, Baiada A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis. 2015 Dec;74(12):2175-82. doi: 10.1136/annrheumdis-2014-205681. Epub 2014 Aug 11.

  PMID: 25114060 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• loic MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 18, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

FR (1)