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Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis (scleradec2)

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ClinicalTrials.gov Identifier: NCT02558543
Recruitment Status : Terminated
First Posted : September 24, 2015
Last Update Posted : March 5, 2019
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.

. 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.


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

Detailed Description:

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.

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. Secondary efficacy endpoints evaluated at 2 months (M2) and 6 months (M6) showed an improvement in disability, pain, severity of Raynaud's phenomenon, trophicity, the number of digital ulcers, hand mobility and in the quality of life. These encouraging results have encouraged the investigators to propose a trial which would bear on a higher number of patients and include a control group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Active Comparator: Stromal Vascular Fraction
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 Comparator: Placebo
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
Other Name: Placebo




Primary Outcome Measures :
  1. Cochin hand functional scale [ Time Frame: 3 months ]
    effects of SVF injections in the fingers of patients suffering from SSc evaluated at 3 months, in comparison to the control group


Secondary Outcome Measures :
  1. the pain in the hands (EVA pain scale), [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc on evaluated at 1.3 and 6 months, in comparison to the control group

  2. the quality of life- score adapted to scleroderma (SHAQ) [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group

  3. the mobility(score de Kapandji et distance pulpe/pli palmaire distal) [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group

  4. the strength(Jamar et Pinch test) [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group

  5. the finger tactile sensitivity [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group

  6. the trouble trophicity (health assesment questionnaire) [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group concerning trophicity: Rodnan score modified for the hand, finger circumference with a ring sizer, monitoring of existing ulcers and of the onset of new ulcers

  7. the severity (frequency and intensity of crises) of Raynaud's phenomenon [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group concerning severity of Raynaud's phenomenon

  8. the vascular suppression score [ Time Frame: 6 months ]
    effects of SVF injections in the fingers of patients suffering from SSc , evaluated at 1.3 and 6 months, in comparison to the control group concerning vascular suppression score calculated using nail-fold capillaroscopy



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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): NCT02558543


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Brigitte GRANEL, MD Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02558543     History of Changes
Other Study ID Numbers: 2014-003321-17
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases