Lupus NephritisPhase 1NCT04318600
Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis
A Phase 1 study testing human amniotic mesenchymal stem cell in people with Lupus Nephritis and Mesenchymal Stem Cells, run by Yan'an Affiliated Hospital of Kunming Medical University.
Trial summary
This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis (LN). Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Lupus Nephritis, Mesenchymal Stem Cells
- What is being tested?
- human amniotic mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2019
- Phase
- Phase 1
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients with kidney biopsy diagnosis of type I, VI lupus nephritis or a diagnosis of another glomerular disease;
- Patients with abnormal renal function (serum creatinine ≥ the upper limit of normal);
- Patients with active liver disease or abnormal liver function test results (ALT or AST ≥2 times the upper limit of normal);
- Patients with blood leukocyte count <2.5 × 109/L, hemoglobin <90 g/L, platelet count <100 × 109/L, or those who have other hematologic diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation dysfunction, etc.);
- Patients with serious and unstable cardiovascular or cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control the disease, after treatment has not been effectively controlled severe hypertension (blood pressure >160/100 mm Hg), or organ transplantation;
- Patients with uncontrolled infection;
Show all 13Show fewer
- Patients with tumors or abnormal tumor marker levels; 8. Patients with blood-borne diseases (i.e., HIV, syphilis, hepatitis B, and hepatitis C);
- Pregnancy, the potential for pregnancy, or lactation;
- Patients with a history of allergy, especially patients allergic to human blood albumin;
- Patients with mental illness affecting their voluntarism, ability to make decisions, and ability to communicate；
- A history of alcoholism or known drug addiction in the last 2 years;
- Participation in another clinical trial within the last 3 months;
- Patients judged inappropriate for this study by the physicians.
About this study
This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis (LN).
Read the detailed description
Eleven patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). At the same time, five patients with LN who were not given hA-MSC as the blank control group. All patients did not received intravenous corticosteroids pulse therapy, but the use of oral corticosteroids and intravenous cyclophosphamide, or oral mycophenolate mofetil, tacrolimus , leflunomide were allowed.
- Conditions
- Lupus Nephritis, Mesenchymal Stem Cells
- Being tested
- human amniotic mesenchymal stem cell
- Keywords
- Lupus Nephritis, Human Amniotic Mesenchymal Stem Cell, cell therapy, clinical trail
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human amniotic mesenchymal stem cellDrug
human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times).
| Study group | Role | What they receive |
|---|---|---|
| human amniotic mesenchymal stem cell treatment group | Experimental | Not described Receives: Drug: human amniotic mesenchymal stem cell |
| blank control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study. Describe the association with Amniotic mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events.
Measured: 60 weeks
Secondary outcomes (3)
Changes in 24h urine protein quantification before and after treatment；
24-hour urinary protein quantification from baseline to 60 weeks of treatment.
Measured: 60 weeks
Changes in eGFR before and after treatment;
changes in estimated glomerular filtration rate (eGFR) from baseline to 60 weeks of treatment.
Measured: 60 weeks
Changes in SLEDAI score before and after treatment；
changes in SLEDAI score from baseline to 60 weeks of treatment. SLEDAI score: 0~4 points basically no activity;5-9 minutes light activity;10-14 minutes of moderate activity;≥15 minutes of severe activity.
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Jan 2014
- Primary completion1 Mar 2017
- Study completion1 Jan 2019
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 NephritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Yunnan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318600
- Sponsor's protocol ID
- 2014001
- Status last verified
- Jan 2014
- First submitted
- 11 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naeem A, Gupta N, Naeem U, Khan MJ, Elrayess MA, Cui W, Albanese C. A comparison of isolation and culture protocols for human amniotic mesenchymal stem cells. Cell Cycle. 2022 Aug;21(15):1543-1556. doi: 10.1080/15384101.2022.2060641. Epub 2022 Apr 12.
PubMed 35412950
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04318600
- Acronym / sponsor ID
- 2014001
- Conditions
- Lupus Nephritis, Mesenchymal Stem Cells
- Keywords
- Lupus Nephritis, Human Amniotic Mesenchymal Stem Cell, cell therapy, clinical trail
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- The First People's Hospital of Yunnan
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 24 Mar 2020 (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.
This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis (LN).
Detailed description
Eleven patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). At the same time, five patients with LN who were not given hA-MSC as the blank control group. All patients did not received intravenous corticosteroids pulse therapy, but the use of oral corticosteroids and intravenous cyclophosphamide, or oral mycophenolate mofetil, tacrolimus , leflunomide were allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human amniotic mesenchymal stem cell treatment group | Experimental | Drug: human amniotic mesenchymal stem cell |
| blank control group | No intervention | – |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients with kidney biopsy diagnosis of type I, VI lupus nephritis or a diagnosis of another glomerular disease;
- Patients with abnormal renal function (serum creatinine ≥ the upper limit of normal);
- Patients with active liver disease or abnormal liver function test results (ALT or AST ≥2 times the upper limit of normal);
- Patients with blood leukocyte count <2.5 × 109/L, hemoglobin <90 g/L, platelet count <100 × 109/L, or those who have other hematologic diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation dysfunction, etc.);
- Patients with serious and unstable cardiovascular or cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control the disease, after treatment has not been effectively controlled severe hypertension (blood pressure >160/100 mm Hg), or organ transplantation;
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 |
|---|---|---|
| human amniotic mesenchymal stem cellhuman amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). | Drug | human amniotic mesenchymal stem cell treatment group |
Primary outcome
Incidence of Adverse Events
Time frame: 60 weeks
The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study. Describe the association with Amniotic mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events.
3 secondary outcomes
Changes in 24h urine protein quantification before and after treatment；
Time frame: 60 weeks
Changes in eGFR before and after treatment;
Time frame: 60 weeks
Changes in SLEDAI score before and after treatment；
Time frame: 60 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 35412950Naeem A, Gupta N, Naeem U, Khan MJ, Elrayess MA, Cui W, Albanese C. A comparison of isolation and culture protocols for human amniotic mesenchymal stem cells. Cell Cycle. 2022 Aug;21(15):1543-1556. doi: 10.1080/15384101.2022.2060641. Epub 2022 Apr 12.
Related trials for Lupus Nephritis
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus Nephritis
RecruitingObservational study
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
SLE - Systemic Lupus Erythematosus
RecruitingObservational study
Study of Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Not yet recruitingPhase 1/2
CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Active, not recruitingPhase 3
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Lupus Nephritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human amniotic mesenchymal stem cell in people with Lupus Nephritis and Mesenchymal Stem Cells, run by Yan'an Affiliated Hospital of Kunming Medical University.
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 0 inclusion and 13 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: finished, as of the sponsor's last update on 24 Mar 2020. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 60 weeks). 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 NCT04318600, 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 24 Mar 2020.