A Phase 2/3 interventional study of Intravenous infusion of MSCs and Etanercept in Spondylitis, Spondylitis, Ankylosing and Ankylosis, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-24.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2/3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to treat this disease.
Ankylosing spondylitis (AS) is a chronic, progressive inflammatory rheumatic disease involving primarily the sacroiliac joints and the axial skeleton. The main clinical features are back pain and progressive stiffness of the spine. Oligoarthritis of the hips and shoulders, enthesopathy, and anterior uveitis are common, and involvement of the heart and lungs is rare. The current understanding of the pathogenesis of this disorder is limited.It mainly about to hereditary susceptibility (eg HLA-B27),infection and autoimmunity.
Although traditional drugs, such as Nonsteroidal antiinflammatory drugs (NSAIDs) disease-modifying antirheumatic drugs (DMARDs such as methotrexate, salicylazosulfapyridine OR thalidomide) and steroids have been used in the treatment of AS, however, many studies have indicated that the overall response to these drugs is not satisfied. Addition, the severe side effects of these drugs have also been observed. The management of AS patients therefore remains unsatisfactory and targeted therapies are needed. Although the application of TNF alpha receptor inhibitor (such as Etanercept) has got the success in the early treatment of ankylosing spondylitis, the tolerance to this biological agent make the therapy to this disease rather difficult. Recently, owning to its immunoregulatory, immunosuppressive, stimulating hematopoiesis and tissue repairing properties, the infusion of human MSCs isolated from human bone marrow have been a promising and effective treatment to AS patients. This study will evaluate the safety and effectiveness of MSC transplantation in the AS patients and compare the efficiency with the Etanercept to treat AS patients.
This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant therapy (experimental group) or Etanercept therapy (control group). Patients will undergo MSC transplant at the start of the study on Day 0. The experimental group will receive infusion per week in the first 4 weeks and every two weeks in the second 8 weeks, totally for 12 weeks. After 3 months, patients will receive the second MSC transplantation. After 12 weeks (Phase I) and 48 weeks (Phase II) from the first transplantation, patients will be evaluated.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 250 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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Exclusion Criteria:
Human bone marrow-derived MSCs at a dose of 1.0E+6 MSC/kg, receive infusion per week in the first 4 weeks and every two weeks in the second 8 weeks. total for 12 weeks.
Biological: Intravenous infusion of MSCs
50mg,hypodermic injection,once per week, for 12 weeks
Drug: Etanercept
Intravenous infusion of MSCs:Human bone marrow-derived MSCs 1.0E+6 MSC/kg, IV drop
50mg,hypodermic injection,once per week, for 12 weeks
Also known as: TNF alpha receptor inhibitor
The Assessment of Spondyloarthritis International Society (ASAS)20 response
ASAS measures symptomatic improvement in AS patients.ASAS=4 domains:patient global assessment of disease activity,pain,function,inflammation.ASAS 20=20% improvement(vs.baseline)and an absolute change≥1 units on a 0-10 scale(0=no disease activity;10=high disease activity)for ≥3 domains,and no worsening in remaining domain.
Time frame: 48 weeks
BASDAI score comparing to baseline
Time frame: 48 weeks
BASFI score comparing to baseline
the Bath Ankylosing Spondylitis Functional Index
Time frame: 48 weeks
Imageology
The bone marrow of the whole spine (from C2 to S1) can be detected by Magnetic resonance imaging (MRI) scan. The MRI sequence included a T1-weighted turbo spin-echo (TSE) sequence and a fat-saturated short tau inversion recovery (STIR) sequence. MR images were first analyzed using the ASspiMRI-a scoring system , which is based on grading disease activity on a scale of 0 to 6. In addition to the ASspiMRI-a scoring system, the inflammation area and average intensityof each inflammatory site were calculated. The background value (BV) was obtained by taking 10 normal sites of the vertebral body of 1 layer and calculating the average. The inflammation extent of each inflammatory site was calculated by the formula: value of inflammation area (VIA) × \[value of average intensity (VAI) - BV\]. The summation of the inflammation extent of all inflammatory sites in all scanning layers was defined as the total inflammation extent (TIE) of each patient.
Time frame: 48 weeks
C-reactive protein (CRP)
Time frame: 12 weeks
Erythrocyte sedimentation rate (ESR)
Time frame: 12 weeks
Tumor necrosis factor alpha (TNF-α)
Time frame: 12 weeks
Interleukin 6 (IL-6)
Time frame: 12 weeks
Interleukin 17 (IL-17)
Time frame: 12 weeks
Percentage of systemic T cell population
Time frame: 12 weeks
Side effects
These parameters monitored throughout the trial included body temperature, pulse rate, respiration rate, blood pressure, complete blood count (CBC), routine urine and stool testing, blood creatinine, alanine transaminase, and aspartate transaminase levels, anti-nuclear antibody testing, electrocardiogram, and chest radiographs. These data were obtained by skilled allied health professionals strictly according to the international standardized procedure when patients were enrolled in this study.
Time frame: 48 weeks
Plan to share: Undecided — It all depends on the whole process of the study.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University