SCLERoderma et Adipose-DErived Stroma Cells

NCT ID: NCT02866552

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-08-31

Brief Summary

Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis

The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PLACEBO

Patients will receive an injection of placebo

Group Type: PLACEBO_COMPARATOR

Ringer lactate

Intervention Type: DRUG

DRUG : Stromal Vascular Fraction

Patients will receive an injection of Stromal Vascular Fraction injection

Group Type: EXPERIMENTAL

Stromal Vascular fraction

Intervention Type: DRUG

Interventions

Stromal Vascular fraction

Intervention Type: DRUG

Ringer lactate

Intervention Type: DRUG

Other Intervention Names

placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

catherine GEINDRE

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

BRIGITTE GRANEL

Role: PRINCIPAL_INVESTIGATOR

ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Brigitte GRANEL

Role: CONTACT

brigitte.granel@ap-hm.fr

alexandra GIULIANI

Role: CONTACT

alexandra.giuliani@ap-hm.fr

Facility Contacts

BRIGITTE GRANEL

Role: primary

brigitte.granel@ap-hm.fr

Other Identifiers

2016-40

Identifier Type: -

Identifier Source: org_study_id