SCLERoderma et Adipose-DErived Stroma Cells

Systemic Sclerosis Clinical Trial

— SCLERADECIII  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02866552
• Other study ID #: 2016-40
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 5, 2016
• Last updated: August 10, 2016
• Start date: January 2017
• Est. completion date: August 2019

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Brigitte GRANEL
• Email: brigitte.granel[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: August 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

Drug:
• Stromal Vascular fraction

• Ringer lactate

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cochin hand functional scale		12 months	No
Secondary	the severity (frequency and intensity of crises) of Raynaud's phenomenon		12 months	No
Secondary	the strength (Jamar et Pinch test)		12 months	No
Secondary	the trouble trophicity (health assesment questionnaire)		12months	No
Secondary	the pain in the hands (EVA pain scale),		12 months	No