Ankylosing Spondylitis Clinical Trial
Official title:
Phase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat AS
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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