Arthritis Clinical Trial
Official title:
Phase III Study of Human Bone Marrow-Derived Mesenchymal Stem Cells to Treat AS
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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