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SCLERoderma et Adipose-DErived Stroma Cells (SCLERADECIII)

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ClinicalTrials.gov Identifier: NCT02866552
Recruitment Status : Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Stromal Vascular fraction Drug: Ringer lactate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Placebo Comparator: PLACEBO
Patients will receive an injection of placebo
Drug: Ringer lactate
Other Name: placebo

Experimental: DRUG : Stromal Vascular Fraction
Patients will receive an injection of Stromal Vascular Fraction injection
Drug: Stromal Vascular fraction



Primary Outcome Measures :
  1. Cochin hand functional scale [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. the severity (frequency and intensity of crises) of Raynaud's phenomenon [ Time Frame: 12 months ]
  2. the strength (Jamar et Pinch test) [ Time Frame: 12 months ]
  3. the trouble trophicity (health assesment questionnaire) [ Time Frame: 12months ]
  4. the pain in the hands (EVA pain scale), [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866552


Contacts
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Contact: Brigitte GRANEL brigitte.granel@ap-hm.fr
Contact: alexandra GIULIANI alexandra.giuliani@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: BRIGITTE GRANEL       brigitte.granel@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: catherine GEINDRE ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Principal Investigator: BRIGITTE GRANEL ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02866552     History of Changes
Other Study ID Numbers: 2016-40
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases