SCLERoderma et Adipose-DErived Stroma Cells (SCLERADECIII)

August 10, 2016 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Patients will receive an injection of placebo
Drug: Ringer lactate
Other Names:
  • placebo
Experimental: DRUG : Stromal Vascular Fraction
Patients will receive an injection of Stromal Vascular Fraction injection
Drug: Stromal Vascular fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cochin hand functional scale
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the severity (frequency and intensity of crises) of Raynaud's phenomenon
Time Frame: 12 months
12 months
the strength (Jamar et Pinch test)
Time Frame: 12 months
12 months
the trouble trophicity (health assesment questionnaire)
Time Frame: 12months
12months
the pain in the hands (EVA pain scale),
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: catherine GEINDRE, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
  • Principal Investigator: BRIGITTE GRANEL, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Sclerosis

Clinical Trials on Ringer lactate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe