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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. The male or female patient aged 18 to 45 years; 2. Fulfill 1984 modified NewYork classification criteria for AS; 3. The score of the Bath AS Disease Activity Index (BASDAI)=40 on (0-100) despite optimal non-steroidal anti-inflammatory drug (NSAID) treatment. 4. Before each experiment, patients subscribe voluntarily to the agreement approved by Ethics Committees and sign the date. Exclusion Criteria: 1. The patient diagnosed in doubt; 2. Completely stiff spine 3. Received spinal or joint surgery within 2 months 4. Received anti-TNF therapy within 3 months 5. pregnant or suckling period female patients; 6. Patients with the Medical or mentally imbalance charged by researchers. patients associated cardiovascular, cerebrovascular, liver,renal and hematological system diseases or mental disease; 7. Patients could not accept the research or could not cooperate well. Patients with other sever diseases at the same time, such as abnormality of joints, other seronegative spondyloarthropathy, or other Rheumatic Diseases. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Nanfang Hospital of Southern Medical University, Second Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of systemic T cell population | 12 weeks | No | |
Other | 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. | 48 weeks | Yes |
Primary | 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. | 48 weeks | No |
Secondary | BASDAI score comparing to baseline | 48 weeks | No | |
Secondary | BASFI score comparing to baseline | the Bath Ankylosing Spondylitis Functional Index | 48 weeks | No |
Secondary | 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. |
48 weeks | No |
Secondary | C-reactive protein (CRP) | 12 weeks | No | |
Secondary | Erythrocyte sedimentation rate (ESR) | 12 weeks | No | |
Secondary | Tumor necrosis factor alpha (TNF-a) | 12 weeks | No | |
Secondary | Interleukin 6 (IL-6) | 12 weeks | No | |
Secondary | Interleukin 17 (IL-17) | 12 weeks | No |
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