SCLERoderma et Adipose-DErived Stroma Cells (SCLERADECIII)
Primary Purpose
Systemic Sclerosis
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Stromal Vascular fraction
Ringer lactate
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis
Eligibility 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
PLACEBO
DRUG : Stromal Vascular Fraction
Arm Description
Patients will receive an injection of placebo
Patients will receive an injection of Stromal Vascular Fraction injection
Outcomes
Primary Outcome Measures
Cochin hand functional scale
Secondary Outcome Measures
the severity (frequency and intensity of crises) of Raynaud's phenomenon
the strength (Jamar et Pinch test)
the trouble trophicity (health assesment questionnaire)
the pain in the hands (EVA pain scale),
Full Information
NCT ID
NCT02866552
First Posted
August 5, 2016
Last Updated
August 10, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02866552
Brief Title
SCLERoderma et Adipose-DErived Stroma Cells
Acronym
SCLERADECIII
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Patients will receive an injection of placebo
Arm Title
DRUG : Stromal Vascular Fraction
Arm Type
Experimental
Arm Description
Patients will receive an injection of Stromal Vascular Fraction injection
Intervention Type
Drug
Intervention Name(s)
Stromal Vascular fraction
Intervention Type
Drug
Intervention Name(s)
Ringer lactate
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Cochin hand functional scale
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the severity (frequency and intensity of crises) of Raynaud's phenomenon
Time Frame
12 months
Title
the strength (Jamar et Pinch test)
Time Frame
12 months
Title
the trouble trophicity (health assesment questionnaire)
Time Frame
12months
Title
the pain in the hands (EVA pain scale),
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte GRANEL
Email
brigitte.granel@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
alexandra GIULIANI
Email
alexandra.giuliani@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
BRIGITTE GRANEL
Organizational Affiliation
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRIGITTE GRANEL
Email
brigitte.granel@ap-hm.fr
12. IPD Sharing Statement
Learn more about this trial
SCLERoderma et Adipose-DErived Stroma Cells
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