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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813279
• Other study ID #: 2011-A01228-33
• Secondary ID: 2011-28
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: August 29, 2014
• Start date: November 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• the cell therapy
the reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement of the functional index of Cochin		2 years	No
Secondary	Analog visual scale ( EVA )		24 MONTHS	No
Secondary	Evaluation of the severity of the syndrome of Raynaud		24 months	No
Secondary	The test HAMIS		24 months	No
Secondary	The score of Rodnan modified in the hand		24 months	No
Secondary	-The test HAMIS		24 months	No