Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)

NCT ID: NCT01420432

Last Updated: 2011-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS)

Detailed Description

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 MTX,SASP 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. Human MSCs isolated from human umbilical cord/placenta have been shown to have immunoregulatory, immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplantation in the AS patients.

This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant +DMARDs therapy (experimental group) or DMARDs therapy (control group). Patients will undergo MSC transplant at the start of the study on Day 0. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Human umbilical cord-derived MSCs and DMARDs

Human umbilical cord-derived MSCs at a dose of 1.0E+6 MSC/kg, repeated after three months and DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months

Group Type: EXPERIMENTAL

Human umbilical cord-derived MSCs

Intervention Type: BIOLOGICAL

1.0E+6 MSC/kg, IV drop and repeat repeated after three months

DMARDs

DMARDs such as sulfasalazine,methotrexate,thalidomide po for 12 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Human umbilical cord-derived MSCs

1.0E+6 MSC/kg, IV drop and repeat repeated after three months

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient age 18~60 years old with plan to infuse MSCs.

2. Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria

3. Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted

4. Patients must have an ECOG 0~2.

5. No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176 umol/L.

6. No severe infection.

7. Each patient must sign written informed consent.

Exclusion Criteria

1. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)

2. Psychiatric condition that would limit informed consent.

3. HIV, hepatitis B or C, tuberculosis, other infections

4. Positive Pregnancy Test or lactation

5. Patient has enrolled another clinical trial study within last 4 weeks.

6. Contraindications to MSC

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Department of Hematology of the 2nd Hospital of Shandong University

Principal Investigators

chengyun zheng, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology of The 2nd Hospital of Shandong University

Locations

Department of Hematology of the 2nd Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

chengyun zheng, Ph. D

Role: CONTACT

chengyun.zheng@ki.se

+86-531-85875635

Facility Contacts

chengyun zheng, Ph. D

Role: primary

chengyun.zheng@ki.se

+86-531-85875635

Other Identifiers

Zhangni

Identifier Type: -

Identifier Source: org_study_id