|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 July 2016 |
|
Main ID: |
NCT02809781 |
|
Date of registration:
|
16/06/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis
|
|
Scientific title:
|
Phase III Study of Human Bone Marrow-Derived Mesenchymal Stem Cells to Treat AS |
|
Date of first enrolment:
|
June 2016 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02809781 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Shen Huiyong, Doctor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sun Yat-sen Memorial Hospital, Sun Yat-sen University |
|
|
Name:
|
Shen Huiyong, Doctor |
|
Address:
|
|
|
Telephone:
|
+8602081332612 |
|
Email:
|
shenhuiyong@aliyun.com |
|
Affiliation:
|
|
|
|
Name:
|
Shen Huiyong, Doctor |
|
Address:
|
|
|
Telephone:
|
+8602081332612 |
|
Email:
|
shenhuiyong@aliyun.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Spondylitis
|
|
Musculoskeletal Diseases
|
|
Spondylitis, Ankylosing
|
|
Arthritis
|
|
Ankylosis
|
|
Bone Diseases
|
|
Spondylarthropathies
|
|
Spinal Diseases
|
|
Spondylarthritis
|
|
Intervention(s)
|
|
Biological: Intravenous infusion of MSCs
|
|
Drug: Etanercept
|
|
Primary Outcome(s)
|
|
The Assessment of Spondyloarthritis International Society (ASAS)20 response
[Time Frame: 48 weeks]
|
|
Secondary Outcome(s)
|
|
BASFI score comparing to baseline
[Time Frame: 48 weeks]
|
|
C-reactive protein (CRP)
[Time Frame: 12 weeks]
|
|
Imageology
[Time Frame: 48 weeks]
|
|
BASDAI score comparing to baseline
[Time Frame: 48 weeks]
|
|
Interleukin 6 (IL-6)
[Time Frame: 12 weeks]
|
|
Erythrocyte sedimentation rate (ESR)
[Time Frame: 12 weeks]
|
|
Interleukin 17 (IL-17)
[Time Frame: 12 weeks]
|
|
Tumor necrosis factor alpha (TNF-a)
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
SYSU-81332612
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|