A Phase 1 interventional study of Human umbilical cord-derived MSCs in Ankylosing Spondylitis, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-08-19.
Sponsored by Shandong University · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS)
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 MTX,SASP 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. Human MSCs isolated from human umbilical cord/placenta have been shown to have immunoregulatory, immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplantation in the AS patients.
This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant +DMARDs therapy (experimental group) or DMARDs therapy (control group). Patients will undergo MSC transplant at the start of the study on Day 0. After 3 months, patients will receive the second MSC transplantation. After six and twelve months 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 10 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated after three months and DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months
Biological: Human umbilical cord-derived MSCs
DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months
1.0E+6 MSC/kg, IV drop and repeat repeated after three months
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 abosolute 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. Patient global Pain Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI) Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)
Time frame: 1 year
erythrocyte sedimentation rate (ESR)
erythrocyte sedimentation rate (ESR) level will be mainly observed after transplanting 3, 6,12-month.
Time frame: 1 year
imageology
imageology will be mainly observed after transplanting 3, 6,12-month.
Time frame: 1 year
C-reactive protein (CRP)
C-reactive protein (CRP) level will be mainly observed after transplanting 3, 6,12-month.
Time frame: 1 year
Percentage of systemic T regulatory cell population
Percentages of T regulatory cell population in peripheral blood will be tested in every 3 months after transplanting MSCs for one year
Time frame: 1 year
Side effects
Side effects were observed after the treatment
Time frame: 1 year
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Shandong University