Systemic SclerodermasclerabioNCT03629002
BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA
An observational study of Systemic Scleroderma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- Study of the gene expression profile
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Sep 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with systemic scleroderma included in the SCLERADEC 2 trial and healthy volunteers who use a liposuction operation for aesthetic reasons.
Who may be able to join
- Patients with systemic scleroderma:
- fulfilling the inclusion criteria for the SCLERADEC 2 trial: patients with systemic Scleroderma older than 18, desiring a therapeutic alternative and having a functional impotence authenticated by a functional index of Cochin's hand greater than 20.
- having given their consent for the constitution of a sample in the biological collection
- having completed the follow-up visit to M3 of the SCLERADEC 2 study to have responder / non-responder status.
- Healthy volunteers:
- having recourse to a liposuction operation for aesthetic reasons,
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- with a BMI between 18 and 27,
- not declaring chronic diseases,
- having signed the non-opposition
Who cannot join
- Patients with systemic scleroderma:
- Body mass index (weight-to-height ratio squared) less than 18
- Major Sclerodactyly objectified by Rodnan score applied by hand> 16 (out of a total of 18 points)
- Severe tendon retraction of the fingers objectified by a defect extension in passive measure in goniometry> 90 ° C for at least 2 proximal interphalangeal joints
- Digital infection (including infected ulcer, ulcer with local inflammatory signs and clinical suspicion of osteitis)
- Pulmonary arterial hypertension and / or progressive and / or oxygen-dependent pulmonary fibrosis
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- Prescription of a new systemic treatment for Systemic Scleroderma in the month prior to inclusion
- Persons infected with HIV, HCV, HBV, HTLV and syphilis
- Patients on immunosuppressants outside corticosteroid therapy <10 mg / day and methotrexate
- Known hypersensitivity to human albumin
- For healthy patients and volunteers:
- Contraindication to surgery (patients on anticoagulant or antiaggregant, disorders of haemostasis, contraindication to the analgesic protocol used)
- Premenopausal women of childbearing age without contraception
- Minors
- Pregnant or lactating women
- Majors protected by law (under tutorship or curatorship)
- Persons staying in a health or social facility
- People in emergency
- Persons deprived of their liberty
- Inmates
- Non-beneficiaries of a social security scheme
- Absence or refusal of non-opposition
Trial locations and contacts
1 site in 1 country.
Jérémy MAGALON contact
About this study
Official title: BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND
The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.
The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.
A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.
- Conditions
- Systemic Scleroderma
- Being tested
- Study of the gene expression profile
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the gene expression profileBiological
qPCR analysis
| Study group | Role | What they receive |
|---|---|---|
| patients with systemic scleroderma | Use of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial. Receives: Biological: Study of the gene expression profile | |
| healthy volunteers | Recovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery. Receives: Biological: Study of the gene expression profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the gene expression profile
Study of the gene expression profile by qPCR
Measured: 18 months
Secondary outcomes (3)
Phenotypic analysis of the cells composing the stromal vascular fraction
Phenotypic analysis performed by flow cytometry after multiple immunolabelings (CD90, CD14, CD146, CD34, CD45, DRAQ5, NucBlue Fixed Cell Stain (DAPI)) performed in accordance with the recommendations of the International Society for Cellular Therapy (ISCT) and IFATS.
Measured: 18 months
Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
Mesenchymal stem cells (MSCs) obtained by culturing the total stromal vascular fraction without an immunomagnetic selection step.
Measured: 18 months
Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
Endothelial progenitors by a magnetic immuno-separation method (CD144 microbeads kit, Mylteni biotec) for specifically isolating and expanding endothelial progenitor cells.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629002
- Sponsor's protocol ID
- 2018-06
- Other IDs
- IDRCB
- Acronym
- sclerabio
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND
- ClinicalTrials.gov ID
- NCT03629002
- Acronym / sponsor ID
- sclerabio / 2018-06
- Conditions
- Systemic Scleroderma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 14 Aug 2018 (actual)
- 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.
The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.
The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.
A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with systemic scleroderma | – | Biological: Study of the gene expression profileUse of the biological collection of the vascualire stromal fraction of the SCLERADEC 2 clinical trial. |
| healthy volunteers | – | Biological: Study of the gene expression profileRecovery of a sample of adipose tissue during a liposuction operation in a context of routine cosmetic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic scleroderma included in the SCLERADEC 2 trial and healthy volunteers who use a liposuction operation for aesthetic reasons.
Key inclusion criteria (9 listed)
- fulfilling the inclusion criteria for the SCLERADEC 2 trial: patients with systemic Scleroderma older than 18, desiring a therapeutic alternative and having a functional impotence authenticated by a functional index of Cochin's hand greater than 20.
- having given their consent for the constitution of a sample in the biological collection
- having completed the follow-up visit to M3 of the SCLERADEC 2 study to have responder / non-responder status.
- having recourse to a liposuction operation for aesthetic reasons,
- with a BMI between 18 and 27,
Key exclusion criteria (22 listed)
- Body mass index (weight-to-height ratio squared) less than 18
- Major Sclerodactyly objectified by Rodnan score applied by hand> 16 (out of a total of 18 points)
- Severe tendon retraction of the fingers objectified by a defect extension in passive measure in goniometry> 90 ° C for at least 2 proximal interphalangeal joints
- Digital infection (including infected ulcer, ulcer with local inflammatory signs and clinical suspicion of osteitis)
- Pulmonary arterial hypertension and / or progressive and / or oxygen-dependent pulmonary fibrosis
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 |
|---|---|---|
| Study of the gene expression profileqPCR analysis | Biological | healthy volunteers, patients with systemic scleroderma |
Primary outcome
Study of the gene expression profile
Time frame: 18 months
Study of the gene expression profile by qPCR
3 secondary outcomes
Phenotypic analysis of the cells composing the stromal vascular fraction
Time frame: 18 months
Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
Time frame: 18 months
Cell culture of the stromal vascular fraction to isolate and expand two populations of interest
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Jérémy MAGALON contact
Jean-Olivier ARNAUD study director
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Scleroderma, 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 9 inclusion and 22 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 14 Aug 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jérémy MAGALON (jeremy.magalon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the gene expression profile (time frame: 18 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 14 Aug 2018.