Lupus ErythematosusPhase 1/2MSC-SLENCT03562065
Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord
A Phase 1/2 study testing mesenchymal stem cells in people with Lupus Erythematosus and Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Erythematosus, Stem Cell Transplant
- What is being tested?
- mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2019to 1 Jun 2024
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years and < 70 years.
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the ACR criteria with positive antinuclear antibodies.
- Subjects with sustained disease activity defined by a SELENA- SLEDAI SLE activity index ≥ 6 at baseline,
- Inefficacy or adverse effects necessitating discontinuation of first and second line therapies of SLE including:
- Prednisone orally ≥ 6 mg / day (or equivalent) for at least 28 days. b. At least one or more of the following immunosuppressive therapies for 3 months in total: i- Cyclophosphamide, iv bolus ≥500 mg / month for 3 months minimum ii- Mycophenolate mofetil, orally or equivalent at a dose> 2000 mg / day for at least 90 days iii- Azathioprine orally at a dose> 2 mg / kg / day for at least 90 days; iv- Methotrexate orally or parenterally, at doses > 20mg / week for at least 90 days; v- Leflunomide orally, at a dose of> 10-mg / day for at least 90 days; vi- Rituximab (anti-CD20) intravenous bolus 375 mg / m2, once a week for four weeks or total dose of 1 g twice a day for two weeks vii- Cyclosporine orally, at a dose of 2.5-5 mg / kg / day, for at least 90 days; viii- Belimumab intravenously at monthly bolus of 10 mg / kg infusion), for at least 3 months.
- Patient who received treatment of SLE at stable doses for a minimum of 30 days prior to eligibility, including one of the following treatments: prednisone (or equivalent) alone or combined with antimalarial treatment, an anti-inflammatory steroidal and / or an immunosuppressant.
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- Negative pregnancy test for women of childbearing age.
- For men and women : Using effective contraceptive methods during treatment and within 3 months after the end of treatment for men with her partner of childbearing age
- Signed Informed Consent.
- Affiliation to social security.
Who cannot join
- 1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
- Presence of:
- Renal failure: calculated creatinine clearance of <30 ml / min
- Cardiac failure: clinical signs of congestive heart failure; left ventricular ejection fraction <40% on echocardiography; uncontrolled ventricular arrhythmia;
- Hepatitis defined by abnormal levels of transaminases (AST, ALT> 2 x normal) not related to disease activity.
- Respiratory disease: mean PAP> 50 mmHg (echocardiography), respiratory failure defined by a resting blood pressure of oxygen at PaO 2 < 70 mmHg and / or PaCO2 > 50 mmHg without oxygen
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- Severe psychiatric disorders, including severe psychosis related to SLE, which would prevent to give informed consent or to undergo the procedure.
- Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or squamous cell carcinoma or in situ cervix carcinoma.
- Bone marrow failure defined by neutropenia <0.5.109/L, thrombocytopenia <30. 109 / L, anemia < 8 g / dL, lymphopenia CD4 + <200 x 106 / L caused by another disease than SLE.
- Acute or chronic uncontrolled infection: HIV 1/2, HTLV-1/2, Hepatitis B (HBsAg surface antigen), Hepatitis C with positive PCR
- Patient having received belimumab within 2 months of belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline
- Current substance abuse or recent (within 60 days) history of substance abuse
- Patient in periods of exclusion from the national roster of researchers
- Patient with Linguistic or psychological incapacity to sign informed consent
- Patient already included in another study at the same time.
- Poor patient compliance.
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint-Louis Hospital
Paris, 75010
dominique farge, MD PHD, + 33 142499768, dominique.farge-bancel@sls.aphp.fr
Chen Wu, + 33 142499768, chen.wu.tec@gmail.com
About this study
Official title: Treatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies.
According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. The use of allogeneic umbilical cord-derived MSC is based on experimental and human clinical data, particularly produced by Nanjing team (Pr Sun) in China. It is also logical to select SLE patients with the same severity criteria as those used worldwide to validate the efficacy of anti-Blys therapies. Similarly, the analysis of the expected results should take into account criteria similar or comparable to those used for the pivotal clinical trials. This trial is a unique opportunity to set up collaboration between Saint-Louis APHP, clinical expert center for cell therapy in AD, and University College London for cell manufacturing.
- Conditions
- Lupus Erythematosus, Stem Cell Transplant
- Being tested
- mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
Allogeneic Umbilical Cord derived-MSCs injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of:
- 1.10^6 CSM / kg
- 2.10^6 CSM / kg
- 4.10^6 CSM / kg 1 injection during 30min to 1h by Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Phase I-II, Allogeneic Umbilical Cord derived-MSCs injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of:
* 1.10^6 CSM / kg
* 2.10^6 CSM / kg
* 4.10^6 CSM / kg 1 injection during 30min to 1h by Intravenous infusion Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of allogeneic MSC injection according to CTCAE
Immediate tolerance as assessed after the first allogeneic MSC injection, according to standards CTCAE side effects. An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
Measured: 10 days
Secondary outcomes (36)
Toxicity of allogeneic MSC injection according to CTCAE Month 1
Tolerance according to side effects defined by CTCAE standards (Miller Results of cancer treatment Cancer 1981; 47 (1): 207 - 214). Treatment-related toxicity will be analyzed according to the international World Health Organization (WHO) (maximum degree of toxic attacks by the body). An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
Measured: 1 month
Toxicity of allogeneic MSC injection according to CTCAE Month 3
Tolerance according to side effects defined by CTCAE standards (Miller Results of cancer treatment Cancer 1981; 47 (1): 207 - 214). Treatment-related toxicity will be analyzed according to the international World Health Organization (WHO) (maximum degree of toxic attacks by the body). An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
Measured: 3 months
Toxicity of allogeneic MSC injection according to CTCAE Month 6
Tolerance according to side effects defined by CTCAE standards (Miller Results of cancer treatment Cancer 1981; 47 (1): 207 - 214). Treatment-related toxicity will be analyzed according to the international World Health Organization (WHO) (maximum degree of toxic attacks by the body). An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
Measured: 6 months
Toxicity of allogeneic MSC injection according to CTCAE Month 12
Tolerance according to side effects defined by CTCAE standards (Miller Results of cancer treatment Cancer 1981; 47 (1): 207 - 214). Treatment-related toxicity will be analyzed according to the international World Health Organization (WHO) (maximum degree of toxic attacks by the body). An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
Measured: 12 months
Proportion of subjects with Clinical Response Month 3
Proportion of subjects with Major Clinical Response (MCR) and the proportion of subjects with Partial Response Clinic (PCR)
Measured: 3 months
Proportion of subjects with Clinical Response Month 6
Proportion of subjects with Major Clinical Response (MCR) and the proportion of subjects with Partial Response Clinic (PCR)
Measured: 6 months
Proportion of subjects with Clinical Response Month 9
Proportion of subjects with Major Clinical Response (MCR) and the proportion of subjects with Partial Response Clinic (PCR)
Measured: 9 months
Proportion of subjects with Clinical Response Month 12
Proportion of subjects with Major Clinical Response (MCR) and the proportion of subjects with Partial Response Clinic (PCR)
Measured: 12 months
Disease activity measured by the BILAG index Month 3
Disease activity measured by the British Isles Lupus Assessment Group (BILAG) index (min=0 to max=72). The higher value is the higher is the disease activity.
Measured: 3 months
Disease activity measured by SELENA-SLEDAI Month 3
Disease activity measured by the Safety of Estrogens in Lupus National Assessment study (SELENA) of the Systemic lupus erythematosus disease activity index (SLEDAI) (min=0 to max=105). The higher value is the higher is the disease activity.
Measured: 3 months
Disease activity measured by SELENA-SLEDAI Month 6
Disease activity measured by the Safety of Estrogens in Lupus National Assessment study (SELENA) of the Systemic lupus erythematosus disease activity index (SLEDAI) (min=0 to max=105). The higher value is the higher is the disease activity.
Measured: 6 months
Disease activity measured by the BILAG index Month 6
Disease activity measured by the British Isles Lupus Assessment Group (BILAG) index (min=0 to max=72). The higher value is the higher is the disease activity.
Measured: 6 months
Disease activity measured by the BILAG index Month 9
Disease activity measured by the British Isles Lupus Assessment Group (BILAG) index (min=0 to max=72). The higher value is the higher is the disease activity.
Measured: 9 months
Disease activity measured by SELENA-SLEDAI Month 9
Disease activity measured by the Safety of Estrogens in Lupus National Assessment study (SELENA) of the Systemic lupus erythematosus disease activity index (SLEDAI) (min=0 to max=105). The higher value is the higher is the disease activity.
Measured: 9 months
Disease activity measured by the BILAG index Month 12
Disease activity measured by the British Isles Lupus Assessment Group (BILAG) index (min=0 to max=72). The higher value is the higher is the disease activity.
Measured: 12 months
Disease activity measured by SELENA-SLEDAI Month 12
Disease activity measured by the Safety of Estrogens in Lupus National Assessment study (SELENA) of the Systemic lupus erythematosus disease activity index (SLEDAI) (min=0 to max=105). The higher value is the higher is the disease activity.
Measured: 12 months
SRI Month 3
SRI (Systematic lupus erythematosus Responder Index) response rate during follow-up. A SRI response is defined as a binary outcome equal to 1 if all following conditions are validated:
- 4 points reduction of SELENA SLEDAI-score
- no new BILAG A score for an organ
- no more than one new BILAG B score
- no worsening in the overall evaluation of the physician as compared to inclusion values
Measured: 3 months
SRI Month 6
SRI (Systematic lupus erythematosus Responder Index) response rate during follow-up. A SRI response is defined as a binary outcome equal to 1 if all following conditions are validated:
- 4 points reduction of SELENA SLEDAI-score
- no new BILAG A score for an organ
- no more than one new BILAG B score
- no worsening in the overall evaluation of the physician as compared to inclusion values
Measured: 6 months
SRI Month 9
SRI (Systematic lupus erythematosus Responder Index) response rate during follow-up. A SRI response is defined as a binary outcome equal to 1 if all following conditions are validated:
- 4 points reduction of SELENA SLEDAI-score
- no new BILAG A score for an organ
- no more than one new BILAG B score
- no worsening in the overall evaluation of the physician as compared to inclusion values
Measured: 9 months
SRI Month 12
SRI (Systematic lupus erythematosus Responder Index) response rate during follow-up. A SRI response is defined as a binary outcome equal to 1 if all following conditions are validated:
- 4 points reduction of SELENA SLEDAI-score
- no new BILAG A score for an organ
- no more than one new BILAG B score
- no worsening in the overall evaluation of the physician as compared to inclusion values
Measured: 12 months
comorbidities Month 3
Presence of comorbidities
Measured: 3 months
comorbidities Month 6
Presence of comorbidities
Measured: 6 months
comorbidities Month 9
Presence of comorbidities
Measured: 9 months
comorbidities Month 12
Presence of comorbidities
Measured: 12 months
Quality of life Month SF-36 Month 3
Quality of life assessed by the Short Form 36 version 2 (SF-36v2). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 3 months
Quality of life EQ-5D Month 3
EuroQol-5D (EQ-5D) : health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 0 to 5 and a single summary index is obtained by summing all the dimensions (min=0 to max=25).
Measured: 3 months
Quality of life Month SF-36 Month 6
Quality of life assessed by the Short Form 36 version 2 (SF-36v2). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 6 months
Quality of life EQ-5D Month 6
EuroQol-5D (EQ-5D) : health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 0 to 5 and a single summary index is obtained by summing all the dimensions (min=0 to max=25).
Measured: 6 months
Quality of life Month SF-36 Month 9
Quality of life assessed by the Short Form 36 version 2 (SF-36v2). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 9 months
Quality of life EQ-5D Month 9
EuroQol-5D (EQ-5D) : health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 0 to 5 and a single summary index is obtained by summing all the dimensions (min=0 to max=25).
Measured: 9 months
Quality of life Month SF-36 Month 12
Quality of life assessed by the Short Form 36 version 2 (SF-36v2). The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 12 months
Quality of life EQ-5D Month 12
EuroQol-5D (EQ-5D) : health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 0 to 5 and a single summary index is obtained by summing all the dimensions (min=0 to max=25).
Measured: 12 months
Steroids Month 3
Percentage of subjects with an average dose of prednisone reduced by 25% compared to M0
Measured: 3 months
Steroids Month 6
Percentage of subjects with an average dose of prednisone reduced by 25% compared to M0
Measured: 6 months
Steroids Month 9
Percentage of subjects with an average dose of prednisone reduced by 25% compared to M0
Measured: 9 months
Steroids Month 12
Percentage of subjects with an average dose of prednisone reduced by 25% compared to M0
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 posted19 Jun 2018
- Study start11 Sep 2019
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus ErythematosusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03562065
- Sponsor's protocol ID
- P150302
- Acronym
- MSC-SLE
- Status last verified
- Jun 2021
- First submitted
- 22 May 2018
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farge D, Biard L, Weil B, Girault V, Lansiaux P, Munia I, Loisel S, Charles C, Saout J, Resche-Rigon M, Korganow AS, Beuvon C, Pugnet G, Cacciatore C, Abisror N, Taupin JL, Cras A, Lowdell MW, Tarte K. Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study. Lancet Rheumatol. 2025 Apr;7(4):e261-e273. doi: 10.1016/S2665-9913(24)00298-4. Epub 2024 Dec 17.
PubMed 39706212
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord
- ClinicalTrials.gov ID
- NCT03562065
- Acronym / sponsor ID
- MSC-SLE / P150302
- Conditions
- Lupus Erythematosus, Stem Cell Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 19 Jun 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.
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies.
According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. The use of allogeneic umbilical cord-derived MSC is based on experimental and human clinical data, particularly produced by Nanjing team (Pr Sun) in China. It is also logical to select SLE patients with the same severity criteria as those used worldwide to validate the efficacy of anti-Blys therapies. Similarly, the analysis of the expected results should take into account criteria similar or comparable to those used for the pivotal clinical trials. This trial is a unique opportunity to set up collaboration between Saint-Louis APHP, clinical expert center for cell therapy in AD, and University College London for cell manufacturing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cellsPhase I-II, Allogeneic Umbilical Cord derived-MSCs injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of: * 1.10^6 CSM / kg * 2.10^6 CSM / kg * 4.10^6 CSM / kg 1 injection during 30min to 1h by Intravenous infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years and < 70 years.
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the ACR criteria with positive antinuclear antibodies.
- Subjects with sustained disease activity defined by a SELENA- SLEDAI SLE activity index ≥ 6 at baseline,
- Inefficacy or adverse effects necessitating discontinuation of first and second line therapies of SLE including:
- Patient who received treatment of SLE at stable doses for a minimum of 30 days prior to eligibility, including one of the following treatments: prednisone (or equivalent) alone or combined with antimalarial treatment, an anti-inflammatory steroidal and / or an immunosuppressant.
Key exclusion criteria (17 listed)
- 1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
- Presence of:
- Severe psychiatric disorders, including severe psychosis related to SLE, which would prevent to give informed consent or to undergo the procedure.
- Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or squamous cell carcinoma or in situ cervix carcinoma.
- Bone marrow failure defined by neutropenia <0.5.109/L, thrombocytopenia <30. 109 / L, anemia < 8 g / dL, lymphopenia CD4 + <200 x 106 / L caused by another disease than SLE.
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 |
|---|---|---|
| mesenchymal stem cellsAllogeneic Umbilical Cord derived-MSCs injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of: * 1.10^6 CSM / kg * 2.10^6 CSM / kg * 4.10^6 CSM / kg 1 injection during 30min to 1h by Intravenous infusion | Biological | mesenchymal stem cells |
Primary outcome
Toxicity of allogeneic MSC injection according to CTCAE
Time frame: 10 days
Immediate tolerance as assessed after the first allogeneic MSC injection, according to standards CTCAE side effects. An injection will be considered as not tolerated for any toxicity criteria above grade ≥ 3.
36 secondary outcomes
Toxicity of allogeneic MSC injection according to CTCAE Month 1
Time frame: 1 month
Toxicity of allogeneic MSC injection according to CTCAE Month 3
Time frame: 3 months
Toxicity of allogeneic MSC injection according to CTCAE Month 6
Time frame: 6 months
Toxicity of allogeneic MSC injection according to CTCAE Month 12
Time frame: 12 months
Proportion of subjects with Clinical Response Month 3
Time frame: 3 months
Proportion of subjects with Clinical Response Month 6
Time frame: 6 months
Proportion of subjects with Clinical Response Month 9
Time frame: 9 months
Proportion of subjects with Clinical Response Month 12
Time frame: 12 months
Disease activity measured by the BILAG index Month 3
Time frame: 3 months
Disease activity measured by SELENA-SLEDAI Month 3
Time frame: 3 months
Disease activity measured by SELENA-SLEDAI Month 6
Time frame: 6 months
Disease activity measured by the BILAG index Month 6
Time frame: 6 months
Disease activity measured by the BILAG index Month 9
Time frame: 9 months
Disease activity measured by SELENA-SLEDAI Month 9
Time frame: 9 months
Disease activity measured by the BILAG index Month 12
Time frame: 12 months
Disease activity measured by SELENA-SLEDAI Month 12
Time frame: 12 months
SRI Month 3
Time frame: 3 months
SRI Month 6
Time frame: 6 months
SRI Month 9
Time frame: 9 months
SRI Month 12
Time frame: 12 months
comorbidities Month 3
Time frame: 3 months
comorbidities Month 6
Time frame: 6 months
comorbidities Month 9
Time frame: 9 months
comorbidities Month 12
Time frame: 12 months
Quality of life Month SF-36 Month 3
Time frame: 3 months
Quality of life EQ-5D Month 3
Time frame: 3 months
Quality of life Month SF-36 Month 6
Time frame: 6 months
Quality of life EQ-5D Month 6
Time frame: 6 months
Quality of life Month SF-36 Month 9
Time frame: 9 months
Quality of life EQ-5D Month 9
Time frame: 9 months
Quality of life Month SF-36 Month 12
Time frame: 12 months
Quality of life EQ-5D Month 12
Time frame: 12 months
Steroids Month 3
Time frame: 3 months
Steroids Month 6
Time frame: 6 months
Steroids Month 9
Time frame: 9 months
Steroids Month 12
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 8 Jul 2021.
- Derived from this study: PubMed 39706212Farge D, Biard L, Weil B, Girault V, Lansiaux P, Munia I, Loisel S, Charles C, Saout J, Resche-Rigon M, Korganow AS, Beuvon C, Pugnet G, Cacciatore C, Abisror N, Taupin JL, Cras A, Lowdell MW, Tarte K. Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study. Lancet Rheumatol. 2025 Apr;7(4):e261-e273. doi: 10.1016/S2665-9913(24)00298-4. Epub 2024 Dec 17.
- Individual participant dataSharing planned: Undecided
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Cutaneous Lupus Erythematosus (CLE)
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Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cells in people with Lupus Erythematosus and Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 17 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 8 Jul 2021. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Dominique Farge, MD PhD (142499768 ext. +33, dominique.farge-bancel@sls.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity of allogeneic MSC injection according to CTCAE (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562065, which also lists 1 linked publication.
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 8 Jul 2021.