Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis

NCT02558543 | Terminated Phase 2 DMC

• 1 other identifier: 2014-003321-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. . 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. A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of twelve patients to be proven. The encouraging results have encouraged us to propose a trial which would bear on a higher number of patients and include a control group.

Conditions

Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

• Cochin hand functional scale

  effects of SVF injections in the fingers of patients suffering from SSc evaluated at 3 months, in comparison to the control group

  3 months

Secondary Outcomes (8)

• the pain in the hands (EVA pain scale),

  6 months

• the quality of life- score adapted to scleroderma (SHAQ)

  6 months

• the mobility(score de Kapandji et distance pulpe/pli palmaire distal)

  6 months

• the strength(Jamar et Pinch test)

  6 months

• the finger tactile sensitivity

  6 months

Study Arms (2)

Stromal Vascular Fraction

ACTIVE COMPARATOR

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)

Drug: Stromal Vascular fraction

Placebo

PLACEBO COMPARATOR

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)

Drug: Ringer lactate

Interventions

Stromal Vascular fraction DRUG

Stromal Vascular Fraction

Ringer lactate DRUG

Also known as: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Daumas A, Magalon J, Jouve E, Casanova D, Philandrianos C, Abellan Lopez M, Mallet S, Veran J, Auquit-Auckbur I, Farge D, Levesque H, Benhamou Y, Arnaud L, Giraudo L, Dumoulin C, Giverne C, Boyer O, Giuliani A, Bourgarel V, Harle JR, Schleinitz N, Brunet J, Pers YM, Ferreira R, Cras A, Boccara D, Larghero J, Chateau J, Hot A, Dignat-George F, Magalon G, Sabatier F, Granel B. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis. Rheumatology (Oxford). 2022 May 5;61(5):1936-1947. doi: 10.1093/rheumatology/keab584.

  PMID: 34297066 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Brigitte GRANEL, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 24, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

FR (1)