Systemic SclerosisPhase 2SCLERADECIIINCT02866552
SCLERoderma et Adipose-DErived Stroma Cells
A Phase 2 study testing Stromal Vascular fraction and Ringer lactate in people with Systemic Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Stromal Vascular fraction and Ringer lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brigitte GRANEL contact
alexandra GIULIANI contact
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, 13354
BRIGITTE GRANEL, brigitte.granel@ap-hm.fr
About this study
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.
- Conditions
- Systemic Sclerosis
- Being tested
- Stromal Vascular fraction, Ringer lactate
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vascular fractionDrug
Ringer lactateDrug
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Patients will receive an injection of placebo Receives: Drug: Ringer lactate |
| DRUG : Stromal Vascular Fraction | Experimental | Patients will receive an injection of Stromal Vascular Fraction injection Receives: Drug: Stromal Vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochin hand functional scale
Measured: 12 months
Secondary outcomes (4)
the severity (frequency and intensity of crises) of Raynaud's phenomenon
Measured: 12 months
the strength (Jamar et Pinch test)
Measured: 12 months
the trouble trophicity (health assesment questionnaire)
Measured: 12months
the pain in the hands (EVA pain scale),
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- catherine GEINDRE, Study director, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLEBRIGITTE GRANEL, Principal investigator, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866552
- Sponsor's protocol ID
- 2016-40
- Acronym
- SCLERADECIII
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCLERoderma et Adipose-DErived Stroma Cells
- ClinicalTrials.gov ID
- NCT02866552
- Acronym / sponsor ID
- SCLERADECIII / 2016-40
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: Ringer lactatePatients will receive an injection of placebo |
| DRUG : Stromal Vascular Fraction | Experimental | Drug: Stromal Vascular fractionPatients will receive an injection of Stromal Vascular Fraction injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal Vascular fraction | Drug | DRUG : Stromal Vascular Fraction |
| Ringer lactateAlso: placebo | Drug | PLACEBO |
Primary outcome
Cochin hand functional scale
Time frame: 12 months
4 secondary outcomes
the severity (frequency and intensity of crises) of Raynaud's phenomenon
Time frame: 12 months
the strength (Jamar et Pinch test)
Time frame: 12 months
the trouble trophicity (health assesment questionnaire)
Time frame: 12months
the pain in the hands (EVA pain scale),
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte GRANEL contact
alexandra GIULIANI contact
catherine GEINDRE study director
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
BRIGITTE GRANEL principal investigator
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stromal Vascular fraction and Ringer lactate in people with Systemic Sclerosis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigitte GRANEL (brigitte.granel@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochin hand functional scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.