Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT01813279|
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : September 1, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Other: the cell therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||March 2014|
Other: the cell therapy
the reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.
- The improvement of the functional index of Cochin [ Time Frame: 2 years ]
- Analog visual scale ( EVA ) [ Time Frame: 24 MONTHS ]
- Evaluation of the severity of the syndrome of Raynaud [ Time Frame: 24 months ]
- The test HAMIS [ Time Frame: 24 months ]
- The score of Rodnan modified in the hand [ Time Frame: 24 months ]
- -The test HAMIS [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813279
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||loic MONDOLONI||Assistance Publique Hopitaux De Marseille|