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Systemic Lupus ErythematosusPhase 3NCT05631717

The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN

A Phase 3 study testing Human umbilical cord mesenchymal stem cells and Interleukin-2 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus, Lupus Nephritis
What is being tested?
Human umbilical cord mesenchymal stem cells and Interleukin-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Oct 2022to 31 Dec 2025
Phase
Phase 3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Only patients with active lupus nephritis who meet all of the following criteria are eligible for inclusion in this study:
  • Before random assignment, records show that it meets at least 4 of the 11 SLE classification criteria recommended by ACR in 1997.
  • Age: age > 18 years old, ≤ 65 years old when obtaining informed consent
  • SLEDAI-2K score ≥ 6
  • Urinary total protein / creatinine ratio > 1.0 or 24-hour urinary protein > 1.0g, with or without microscopic hematuria
  • If they are fertile, they must agree to use effective contraception during the trial.
  • In the case of women of childbearing age, urinary pregnancy and serum pregnancy tests should be negative.
  • Voluntarily sign informed consent and comply with the requirements of the research programme

Who cannot join

  • Patients who met any of the following criteria could not be enrolled in this study:
  • Patients who had received rituximab or any other B cell depletion therapy within 24 weeks before screening; patients who received unstable doses of mycophenolate mofetil, cyclophosphamide or other immunosuppressants (including Cyclosporine, Tacrolimus, Tripterygium wilfordii, Leflunomide, Azathioprine, Iguratimod) within the first 12 weeks of screening. Received biological agents or small molecule targeted drugs for immune diseases within 4 weeks before screening, such as Etanercept, Infliximab, Adalimumab Solution, Golimumab, Belimumab, Tocilizumab or JAK inhibitors;
  • Plasmapheresis or immunosorbent therapy within 12 weeks before screening.
  • Accompanied by severe and uncontrolled cardiovascular diseases, nervous system diseases, lung diseases, liver diseases, endocrine and gastrointestinal diseases.
  • Current or recent (within 4 weeks before random allocation) a history of severe active or recurrent bacterial, viral, fungal, parasitic or other infections (including, but not limited to, tuberculosis and atypical mycobacterial diseases, hepatitis B and C, HIV infection, herpes zoster, but excluding onychomycosis). Or any infected person who needs hospitalization and intravenous antibiotic treatment within 4 weeks before screening or any infected person who needs treatment within 2 weeks before screening.
  • Any major surgery has been performed within 12 weeks before screening, or major surgery is required during the study period, which the researchers believe will pose an unacceptable risk to the patient;
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  • Live vaccine will be given within 12 weeks before random allocation, or live vaccine is expected to be needed / received during the study (except for herpes zoster vaccination).
  • Patients with a history of malignant tumors, including solid tumors and hematological malignancies (except for excised or cured basal cell carcinoma of the skin);
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Jun Liang, Doctor contact

13505193169 ext. +86

13505193169@139.com

China1 site, 1 recruiting

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Jun Liang, Doctor, 13505193169 ext. +86, 13505193169@139.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-center Study of Comparing the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cells and Low-dose IL-2 in the Treatment of Lupus Nephritis

The purpose of this study is to compare the efficacy and safety of human umbilical cord mesenchymal stem cells and low-dose IL-2 in the treatment of LN

Read the detailed description

Allogeneic MSC transplantation has shown significant efficacy and good safety in the treatment of refractory autoimmune diseases such as lupus nephritis (LN), and has a broad application prospect. One of its mechanisms is that MSCs up-regulates the production of IL-2 and promotes the production of Treg cells. The breakthrough in this technology has brought new hope for patients with autoimmune diseases. Some small sample studies at home and abroad have shown that low-dose IL-2 can be used to treat LN. Recently, the research team found that a single dose of IL-2 showed a longer effect than repeated low-dose MSCs. However, there is still a lack of prospective randomized studies to confirm that the efficacy of allogeneic MSC is better than that of low-dose IL-2. Therefore, carrying out this prospective randomized study will make a real breakthrough in the clinical application of MSC in SLE, and open up a new field for the treatment of SLE for the benefit of mankind.

Being tested
Human umbilical cord mesenchymal stem cells, Interleukin-2
Keywords
Mesenchymal stem cells, interleukin-2
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human umbilical cord mesenchymal stem cellsBiological

    Human umbilical cord mesenchymal stem cells (1 × 10 ^6 cells / kg body weight, suspended in 30ml saline), intravenous drip once.

  • Interleukin-2Drug

    Also called Recombinant Human Interleukin-2(1) for Injection

    IL-2 (1×10^6IU) will be injected subcutaneously every other day for 2 weeks (7 times), with an interval of 2 weeks. 4 weeks is a cycle, and three cycles were continuously treated for 12 weeks.

Study groups in NCT05631717
Study groupRoleWhat they receive
MSCs groupExperimentalIn this group, patients will receive intravenous injection of human umbilical cord mesenchymal stem cells (2 × 10^6 cells / kg body weight, suspended in 30ml saline)
Receives: Biological: Human umbilical cord mesenchymal stem cells
IL-2 groupExperimentalIn this group, patients will receive subcutaneous injection of IL-2 (1×10^6IU) every other day for 2 weeks (7 times), with an interval of 2 weeks.
Receives: Drug: Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rates in both groups （CR and RR）

    Complete response (CR): serum creatinine ≤ 1.2 mg/dl or ≤125% of baseline, and ratio of protein in morning urine to creatinine <0.5 or 24-hour urine protein quantification < 0.5 g, and prednisone reduced to ≤10 mg/day (or equivalent).

    Partial response (PR): if serum creatinine and ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) were abnormal before treatment, both improved by >30% after treatment, and there were no other indicators of deterioration; If only the ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) is abnormal before treatment, the improvement is >50% after treatment.

    Measured: 24 Weeks

Secondary outcomes (9)

  1. Time for both groups of subjects to achieve PR and CR

    Complete response (CR): serum creatinine ≤ 1.2 mg/dl or ≤125% of baseline, and ratio of protein in morning urine to creatinine <0.5 or 24-hour urine protein quantification < 0.5 g, and prednisone reduced to ≤10 mg/day (or equivalent).

    Partial response (PR): if serum creatinine and ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) were abnormal before treatment, both improved by >30% after treatment, and there were no other indicators of deterioration; If only the ratio of protein in morning urine to creatinine (or 24-hour urine protein quantification) is abnormal before treatment, the improvement is >50% after treatment.

    Measured: 24 Weeks

  2. SRI response status

    SRI response status at Week 24 Clinical efficacy will be measured using the SLE Responder Index (SRI), a composite endpoint that incorporates SLEDAI-2K, BILAG 2004, and a visual analog scale (VAS) of physician-rated disease activity to determine patient improvement.

    Measured: 24 Weeks

  3. SLEDAI-2K score and change from baseline

    To describe the effect of treatment with MSCs or IL-2 using patient reported outcomes

    Measured: Baseline, Week 4, 8, 16, 20 and 24

  4. BILAG-2004 score and change from baseline

    To describe the effect of treatment with MSCs or IL-2 using patient reported outcomes

    Measured: Baseline, Week 4, 8, 16, 20 and 24

  5. Hormone dosage and change from baseline

    To describe the effect of treatment with MSCs or IL-2 using dose of hormones in patients

    Measured: Baseline, Week 4, 8, 16, 20 and 24

  6. Patient incidence of Treatment-Emergent Adverse Events

    To characterize the safety of MSCs and IL-2

    Measured: 24 Weeks

  7. Patient incidence of Serious adverse events

    To characterize the safety of MSCs and IL-2

    Measured: 24 Weeks

  8. Number of patients with significant changes in laboratory values

    To characterize the safety of MSCs and IL-2

    Measured: 24 Weeks

  9. Number of patients with significant changes in vital signs

    To characterize the safety of MSCs and IL-2

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start1 Oct 2022
  3. Primary completionJun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The test will be divided into two groups. One group of subjects will receive intravenous injection of human umbilical cord mesenchymal stem cells (2 × 106 cells/kg body weight, suspended in 30ml of normal saline); the other group will receive IL-2 (1 × 106 IU) every other day. Subcutaneous injection for 2 weeks (a total of 7 injections), with an interval of 2 weeks, such that 4 weeks is a cycle, and three consecutive cycles of treatment for a total of 12 weeks.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631717
Sponsor's protocol ID
2022-LCYJ-MS-38
Status last verified
Sep 2022
First submitted
13 Nov 2022
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Geng L, Xu X, Zhang H, Chen C, Hou Y, Yao G, Wang S, Wang D, Feng X, Sun L, Liang J. Comprehensive expression profile of long non-coding RNAs in Peripheral blood mononuclear cells from patients with neuropsychiatric systemic lupus erythematosus. Ann Transl Med. 2020 Mar;8(6):349. doi: 10.21037/atm.2020.03.25.

    PubMed 32355793

  • Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.

    PubMed 30428931

  • Zhang H, Liang J, Qiu J, Wang F, Sun L. Ultrasonographic evaluation of enthesitis in patients with ankylosing spondylitis. J Biomed Res. 2017 Jan 19;31(2):162-169. doi: 10.7555/JBR.31.20160088.

    PubMed 28808198

  • Zhang H, Liang J, Tang X, Wang D, Feng X, Wang F, Hua B, Wang H, Sun L. Sustained benefit from combined plasmapheresis and allogeneic mesenchymal stem cells transplantation therapy in systemic sclerosis. Arthritis Res Ther. 2017 Jul 19;19(1):165. doi: 10.1186/s13075-017-1373-2.

    PubMed 28724445

  • Liang J, Zhang H, Zhao C, Wang D, Ma X, Zhao S, Wang S, Niu L, Sun L. Effects of allogeneic mesenchymal stem cell transplantation in the treatment of liver cirrhosis caused by autoimmune diseases. Int J Rheum Dis. 2017 Sep;20(9):1219-1226. doi: 10.1111/1756-185X.13015. Epub 2017 Feb 20.

    PubMed 28217916

  • Chen C, Liang J, Yao G, Chen H, Shi B, Zhang Z, Zhao C, Zhang H, Sun L. Mesenchymal stem cells upregulate Treg cells via sHLA-G in SLE patients. Int Immunopharmacol. 2017 Mar;44:234-241. doi: 10.1016/j.intimp.2017.01.024. Epub 2017 Jan 25.

    PubMed 28129605

  • Liang J, Wang F, Wang D, Zhang H, Zhao C, Wang S, Sun L. Transplantation of mesenchymal stem cells in a laryngeal carcinoma patient with radiation myelitis. Stem Cell Res Ther. 2015 Nov 4;6:213. doi: 10.1186/s13287-015-0203-1.

    PubMed 26537898

  • Liang J, Sun L. Mesenchymal stem cells transplantation for systemic lupus erythematosus. Int J Rheum Dis. 2015 Feb;18(2):164-71. doi: 10.1111/1756-185X.12531. Epub 2015 Jan 22.

    PubMed 25611801

  • Liang J, Zhang H, Wang D, Feng X, Wang H, Hua B, Liu B, Sun L. Allogeneic mesenchymal stem cell transplantation in seven patients with refractory inflammatory bowel disease. Gut. 2012 Mar;61(3):468-9. doi: 10.1136/gutjnl-2011-300083. Epub 2011 May 26. No abstract available.

    PubMed 21617158

  • Liang J, Li X, Zhang H, Wang D, Feng X, Wang H, Hua B, Liu B, Sun L. Allogeneic mesenchymal stem cells transplantation in patients with refractory RA. Clin Rheumatol. 2012 Jan;31(1):157-61. doi: 10.1007/s10067-011-1816-0. Epub 2011 Aug 12.

    PubMed 21837432

  • Liang J, Zhang H, Hua B, Wang H, Lu L, Shi S, Hou Y, Zeng X, Gilkeson GS, Sun L. Allogenic mesenchymal stem cells transplantation in refractory systemic lupus erythematosus: a pilot clinical study. Ann Rheum Dis. 2010 Aug;69(8):1423-9. doi: 10.1136/ard.2009.123463.

    PubMed 20650877

  • Liang J, Gu F, Wang H, Hua B, Hou Y, Shi S, Lu L, Sun L. Mesenchymal stem cell transplantation for diffuse alveolar hemorrhage in SLE. Nat Rev Rheumatol. 2010 Aug;6(8):486-9. doi: 10.1038/nrrheum.2010.80. Epub 2010 Jun 1.

    PubMed 20517294

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human umbilical cord mesenchymal stem cells and Interleukin-2 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

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 8 inclusion and 9 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 30 Nov 2022. 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 China. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jun Liang, Doctor (13505193169 ext. +86, 13505193169@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rates in both groups （CR and RR） (time frame: 24 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 NCT05631717, which also lists 12 linked publications.

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 30 Nov 2022.

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