A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Nanfang Hospital of Southern Medical University; Second Affiliated Hospital of Guangzhou Medical University
• Treatments: Etanercept

Criteria

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.