SCLERoderma et Adipose-DErived Stroma Cells

NCT02866552 | Unknown Phase 2 DMC

• 1 other identifier: 2016-40
• Study Type: interventional
• Target: 44
• 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. 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

Outcome Measures

Primary Outcomes (1)

• Cochin hand functional scale

  12 months

Secondary Outcomes (4)

• the severity (frequency and intensity of crises) of Raynaud's phenomenon

  12 months

• the strength (Jamar et Pinch test)

  12 months

• the trouble trophicity (health assesment questionnaire)

  12months

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

  12 months

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

Patients will receive an injection of placebo

Drug: Ringer lactate

DRUG : Stromal Vascular Fraction

EXPERIMENTAL

Patients will receive an injection of Stromal Vascular Fraction injection

Drug: Stromal Vascular fraction

Interventions

Stromal Vascular fraction DRUG

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
• 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

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

• catherine GEINDRE

  ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

  STUDY DIRECTOR

• BRIGITTE GRANEL

  ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte GRANEL

CONTACT

brigitte.granel@ap-hm.fr

alexandra GIULIANI

CONTACT

alexandra.giuliani@ap-hm.fr

Study Design

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

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 15, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

FR (1)