clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-11001417
• Date of registration: 2011-07-10
• Prospective Registration: No
• Primary sponsor: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
• Public title: clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis
• Scientific title: clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis
• Date of first enrolment: 2011-06-01
• Target sample size: 1:80;2:80;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8122
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: I+II (Phase I+Phase II)

Countries of recruitment

China

Contacts

• Name: Hui-yong Shen.

• Name: Peng Wang
• Affiliation: Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Key inclusion & exclusion criteria

Inclusion criteria: 1. The male or female patient aged 14 to 60 years;
2. The AS which was diagnosed by physical examination, laboratory and imaging examinations was included (The modified New York criteria (1984));
3. 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. pregnant or suckling period female patients;
3. Patients with the Medical or mentally imbalance charged by researchers. patients associated cardiovascular, cerebrovascular, liver,renal and hematological system diseases or mental disease;
4. 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:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis (AS)

Intervention(s)

1:oral salicylazosulfapyridine and indomethacin;2:Mecenchymal Stem Cells(MSC) transplantation ;

Primary Outcome(s)

pain degree of peripheral joints with visual analog scale (VAS);CD4+ T cell, CD8+ T cell, NK cell, Th17, Treg cells account;AS spine MRI;pain degree at night with visual analog scale (VAS);Bath Ankylosing Spondylitis Disease Activity Index;Serum ESR;Serum CRP;bath ankylosing spondylitis patient global score (BAS-G);Bath Ankylosing Spondylitis Functional Index (BASFI);pain degree of spine with visual analog scale (VAS);

Secondary Outcome(s)

Serum BMP;Serum TNF-alpha;Serum IL17/2;

Source(s) of Monetary Support

Sun Yat-sen Memorial Hospital of Sun Yat-sen University