Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis (scleradec2)
Scleroderma, Systemic
About this trial
This is an interventional treatment trial for Scleroderma, Systemic
Eligibility Criteria
Inclusion Criteria:
- Systemic Sclerosis ( limited or diffuse cutaneous shape)
- Men and women of more than 18 years old
- Patients wishing for a therapeutic alternative
- Functional Disability of the dominant hand authenticated by a functional index of the hand of Cochin functional scale upper to 20
Exclusion Criteria:
- Body mass index (weight in kilograms divided by height in meters squared) lower than 18
- Finger infection (including infected ulcer, ulcer with signs of local inflammation and clinical suspicion of osteitis)
- Contraindication to surgery
- Prescription of a new systemic treatment for SSc in the month before the inclusion
- Subjects infected with HIV, HCV ( hepatitis C virus) , HBV (hepatitis B virus), HTLV ( human T-cell leukemia virus) and syphilis
- Pre-menopausal women of reproductive age, taking no contraceptive method
- Patients receiving immunosuppressive therapy not including corticosteroid therapy < 10 mg/D and methotrexate
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Stromal Vascular Fraction
Placebo
The injection is made for the patients of the both groups in the sub-dermic plan on the side faces of fingers distal and proximal or 4 times 0,25ml by finger, all in all every finger will be injected of 1ml of diluted Stromal Vascular Fraction ( experimental group) , or placebo (ringer lactate) ( placebo group)
The injection is made for the patients of the both groups in the sub-dermic plan on the side faces of fingers distal and proximal or 4 times 0,25ml by finger, all in all every finger will be injected of 1ml of diluted Stromal Vascular Fraction ( experimental group) , or placebo ( placebo group)