None listed
Conditions
Brief 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. 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. This trial will evaluate the safety of MSCs for the treatment of adults with moderate to severely active SLE.
Interventions
SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion. Participants will receive a single IV infusion of Mesenchymal Stem Cells (MSCs) 1 x 10^6 cells/kg in Plasma-Lyte A solution. All patients received standard immunosuppressive treatment, which consisted of intravenous methylprednisolone and cyclophosphamide, followed by maintenance oral prednisolone and mycophenolate mofetil. All participants will receive the infusion at the B
SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion. Participants will receive a single IV infusion of Mesenchymal Stem Cells (MSCs) 1 x 10^6 cells/kg in Plasma-Lyte A solution. All patients received standard immunosuppressive treatment, which consisted of intravenous methylprednisolone and cyclophosphamide, followed by maintenance oral prednisolone and mycophenolate mofetil. All participants will receive the infusion at the Baseline (Day 0) visit. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect.
Sponsors
Stem Cell Centre of Affiliated Hospital of Inner Mongolia Medical University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997. Historical presence of at least 4 of 11 of the ACR Classification Criteria. Evidence of a positive ANA ( greater than or equal to 1:80 titer) or positive dsDNA antibody test within 6 months of screening. No serious infection or acute hemorrhage. Both transaminase and serum creatinine level are more than twice times the upper limit of normal. No acute infectious diseases. Able and willing to give written informed consent.
Exclusion criteria
SLE(Systemic lupus erythematosus) with severe infection. Severe heart attack, liver and kidney disease following serious complications Patients with allergic constitution. Pregnancy and breastfeeding women. Accompanied by malignant tumors or other malignant disease Patients as participant in the other clinical text Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
Outcome results
None listed