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

Primary Purpose

Scleroderma, Systemic

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Stromal Vascular fraction
Ringer lactate
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Active Comparator

Placebo Comparator

Arm Label

Stromal Vascular Fraction

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Cochin hand functional scale
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

the pain in the hands (EVA pain scale),
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
the quality of life- score adapted to scleroderma (SHAQ)
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
the mobility(score de Kapandji et distance pulpe/pli palmaire distal)
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
the strength(Jamar et Pinch test)
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
the finger tactile sensitivity
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
the trouble trophicity (health assesment questionnaire)
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
the severity (frequency and intensity of crises) of Raynaud's phenomenon
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
the vascular suppression score
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

Full Information

First Posted
August 31, 2015
Last Updated
March 4, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02558543
Brief Title
Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis
Acronym
scleradec2
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
March 2019 (Actual)

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. . 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stromal Vascular Fraction
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
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
Description
effects of SVF injections in the fingers of patients suffering from SSc evaluated at 3 months, in comparison to the control group
Time Frame
3 months
Secondary Outcome Measure Information:
Title
the pain in the hands (EVA pain scale),
Description
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
Time Frame
6 months
Title
the quality of life- score adapted to scleroderma (SHAQ)
Description
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
Time Frame
6 months
Title
the mobility(score de Kapandji et distance pulpe/pli palmaire distal)
Description
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
Time Frame
6 months
Title
the strength(Jamar et Pinch test)
Description
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
Time Frame
6 months
Title
the finger tactile sensitivity
Description
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
Time Frame
6 months
Title
the trouble trophicity (health assesment questionnaire)
Description
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
Time Frame
6 months
Title
the severity (frequency and intensity of crises) of Raynaud's phenomenon
Description
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
Time Frame
6 months
Title
the vascular suppression score
Description
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
Time Frame
6 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte GRANEL, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34297066
Citation
Daumas A, Magalon J, Jouve E, Casanova D, Philandrianos C, Abellan Lopez M, Mallet S, Veran J, Auquit-Auckbur I, Farge D, Levesque H, Benhamou Y, Arnaud L, Giraudo L, Dumoulin C, Giverne C, Boyer O, Giuliani A, Bourgarel V, Harle JR, Schleinitz N, Brunet J, Pers YM, Ferreira R, Cras A, Boccara D, Larghero J, Chateau J, Hot A, Dignat-George F, Magalon G, Sabatier F, Granel B. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis. Rheumatology (Oxford). 2022 May 5;61(5):1936-1947. doi: 10.1093/rheumatology/keab584.
Results Reference
derived

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

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