Mesenchymal Stromal CellPre_MSC-AT-SScNCT05947682
Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
A study testing Adipose tissue harvesting in people with Mesenchymal Stromal Cell and Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Mesenchymal stromal cells (MSC) are multipotent cells which carry immunomodulatory, pro-angiogenic and anti-fibrotic properties, that can target Systemic Sclerosis (SSc) pathogenesis and its clinical manifestations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mesenchymal Stromal Cell, Systemic Sclerosis
- What is being tested?
- Adipose tissue harvesting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Feb 2025
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 and ≤ 55 years
- BMI <30
- Non-smoker
- Admission for a pre-scheduled plastic surgery intervention liposuction or lipo-aspiration in the abdominal wall under general anesthesia
- Written consent
- Affiliated to a social security
Who cannot join
- Weight < 50 kg
- Positive viral serology : Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Hepatitis E Virus (HEV), syphilis, Human T Lymphotropic virus (HTLV), active infection with IgM+ for toxoplasmosis, Epsiten Barr Virus (EBV), Cytomegalovirus (CMV)
- Active generalized infection (viral, parasitic, tuberculosis, leprosy...)
- Significant comorbidities according to donor health history or existing risk factors for viral infections within the past 12 months:
- Multiple sexual partners between the donor or his or her usual partner
- Intravenous addiction to the donor or regular partner
Show all 25Show fewer
- Accident of exposure to blood or derivatives suspected of being contaminated
- Uncontrolled hypertension
- Human dura mater transplant
- Surgical history of the central nervous system
- Dementia or neurological disease that may evoke subacute spongiform encephalopathy
- Family history as part of subacute spongiform encephalopathy
- Hematological malignancies
- Active or any past history of cancer
- History of chemotherapy or irradiation
- Systemic or autoimmune disease
- Multiple adenopathy, splenomegaly, hepatomegaly
- Icterus
- Haemophilia
- Known insulin-dependent diabetes
- Treatment with extractive pituitary hormones (including growth hormones)
- Steroids therapy (for more than 5 days) in the past 3 months
- Lithium treatment
- Pregnancy
- Deprived of freedom
Trial locations and contacts
No sites are listed yet.
About this study
Mesenchymal stromal cells (MSC) are multipotent cells which carry immunomodulatory, pro-angiogenic and anti-fibrotic properties, that can target Systemic Sclerosis (SSc) pathogenesis and its clinical manifestations. The increasing use of MSC, harvested from bone marrow (MSC(M)), adipose tissue (MSC(AT)), or umbilical cord (MSC(UC)) in a variety of indications, provides consistent evidence supporting their safety in humans. The efficacy of MSC(M) intravenous (IV) injection for treating acute graft versus host disease led to their marketing approval in 2012 and MSC(AT) (Alofisel) were approved for severe Crohn's fistula in 2018.
MSC represent a promising therapeutic approach for SSc. We previously a) showed disease-specific abnormalities in MSC(M) from SSc patients, providing strong rationale to use allogeneic MSC to treat SSc patients, b) completed the first phase I/II dose escalation trial using allogenic MSC(M) infusion in 20 severe SSc patients (ClinicalTrials.gov: NCT02213705, PHRC AOM 11-250) with no safety issues, significant improvement in skin fibrosis at 3 to 6 months after infusion which appeared lower thereafter, thereby supporting the need for repeated infusions.
Read more
In vitro, experimental and clinical studies suggest that MSC properties vary according to their tissue of origin/source. We demonstrated that compared to MSC(M), MSC(AT) are easier to harvest and display higher proliferative capability before entering senescence, higher genetic stability, and superior immunosuppressive properties.
The objective of the present research is the successful production of allogeneic MSC(AT) derived from selected healthy donors, with adequate phenotypic criteria according to the International Society for Cell \& Gene Therapy.
Considering the above rationale, these MSC(AT) will subsequently be used in a Phase I/II randomized clinical trial testing allogeneic MSC(AT) systemic infusion for treatment of severe systemic sclerosis.
- Conditions
- Mesenchymal Stromal Cell, Systemic Sclerosis
- Being tested
- Adipose tissue harvesting
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue harvestingOther
Adipose tissue harvesting (40-60g) during the abdominal liposuction or lipoaspiration under general anaesthesia which is performed according to usual care
| Study group | Role | What they receive |
|---|---|---|
| Adults who are planned to undergo plastic surgery | Other | Adults who are planned to undergo plastic surgery for abdominal liposuction or lipoaspiration under general anaesthetic for their own care and who are voluntary for fat donation to contribute to the study Receives: Other: Adipose tissue harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of at least 3 batches of MSC(AT) derived from donors adipose tissue
Measured: Up to 2 months
Secondary outcomes (5)
Percentage of viability
Measured: Up to 2 months
Percentage of CD73+ cells
Measured: Up to 2 months
Percentage of CD90+ cells
Measured: Up to 2 months
Percentage of CD105+ cells
Measured: Up to 2 months
Percentage of expression of HLA-DR
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startSep 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stromal CellStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947682
- Sponsor's protocol ID
- APHP230376
- Acronym
- Pre_MSC-AT-SSc
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05947682
- Acronym / sponsor ID
- Pre_MSC-AT-SSc / APHP230376
- Conditions
- Mesenchymal Stromal Cell, Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Jul 2023 (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.
Mesenchymal stromal cells (MSC) are multipotent cells which carry immunomodulatory, pro-angiogenic and anti-fibrotic properties, that can target Systemic Sclerosis (SSc) pathogenesis and its clinical manifestations. The increasing use of MSC, harvested from bone marrow (MSC(M)), adipose tissue (MSC(AT)), or umbilical cord (MSC(UC)) in a variety of indications, provides consistent evidence supporting their safety in humans. The efficacy of MSC(M) intravenous (IV) injection for treating acute graft versus host disease led to their marketing approval in 2012 and MSC(AT) (Alofisel) were approved for severe Crohn's fistula in 2018.
MSC represent a promising therapeutic approach for SSc. We previously a) showed disease-specific abnormalities in MSC(M) from SSc patients, providing strong rationale to use allogeneic MSC to treat SSc patients, b) completed the first phase I/II dose escalation trial using allogenic MSC(M) infusion in 20 severe SSc patients (ClinicalTrials.gov: NCT02213705, PHRC AOM 11-250) with no safety issues, significant improvement in skin fibrosis at 3 to 6 months after infusion which appeared lower thereafter, thereby supporting the need for repeated infusions.
In vitro, experimental and clinical studies suggest that MSC properties vary according to their tissue of origin/source. We demonstrated that compared to MSC(M), MSC(AT) are easier to harvest and display higher proliferative capability before entering senescence, higher genetic stability, and superior immunosuppressive properties.
The objective of the present research is the successful production of allogeneic MSC(AT) derived from selected healthy donors, with adequate phenotypic criteria according to the International Society for Cell \& Gene Therapy.
Considering the above rationale, these MSC(AT) will subsequently be used in a Phase I/II randomized clinical trial testing allogeneic MSC(AT) systemic infusion for treatment of severe systemic sclerosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults who are planned to undergo plastic surgery | Other | Other: Adipose tissue harvestingAdults who are planned to undergo plastic surgery for abdominal liposuction or lipoaspiration under general anaesthetic for their own care and who are voluntary for fat donation to contribute to the study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 55 years
- BMI <30
- Non-smoker
- Admission for a pre-scheduled plastic surgery intervention liposuction or lipo-aspiration in the abdominal wall under general anesthesia
- Written consent
Key exclusion criteria (25 listed)
- Weight < 50 kg
- Positive viral serology : Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Hepatitis E Virus (HEV), syphilis, Human T Lymphotropic virus (HTLV), active infection with IgM+ for toxoplasmosis, Epsiten Barr Virus (EBV), Cytomegalovirus (CMV)
- Active generalized infection (viral, parasitic, tuberculosis, leprosy...)
- Significant comorbidities according to donor health history or existing risk factors for viral infections within the past 12 months:
- Uncontrolled hypertension
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 |
|---|---|---|
| Adipose tissue harvestingAdipose tissue harvesting (40-60g) during the abdominal liposuction or lipoaspiration under general anaesthesia which is performed according to usual care | Other | Adults who are planned to undergo plastic surgery |
Primary outcome
Production of at least 3 batches of MSC(AT) derived from donors adipose tissue
Time frame: Up to 2 months
5 secondary outcomes
Percentage of viability
Time frame: Up to 2 months
Percentage of CD73+ cells
Time frame: Up to 2 months
Percentage of CD90+ cells
Time frame: Up to 2 months
Percentage of CD105+ cells
Time frame: Up to 2 months
Percentage of expression of HLA-DR
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Related trials for Mesenchymal Stromal Cell
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 1
ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
Active, not recruitingPhase 1/2
Intracerebral Transplantation of Autologous MSC Combined With Scaffold Product for Chronic Intracerebral Hemorrhage
Intracerebral Hemorrhage
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.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose tissue harvesting in people with Mesenchymal Stromal Cell and Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 25 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 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Dominique Farge, Pr (+33142499768, dominique.farge-bancel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of at least 3 batches of MSC(AT) derived from donors adipose tissue (time frame: Up to 2 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 17 Jul 2023.