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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treat-to-target Strategy in Ankylosing Spondylitis Using Etanercept and Conventional Synthetic DMARDs

NCT04077957

Ankylosing Spondylitis Spondyloarthritis

UNKNOWN PHASE4

Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study

NCT02489760

Ankylosing Spondylitis

UNKNOWN PHASE4

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

NCT06707194

Spondyloarthritis (SpA) Ankylosing Spondylitis (AS)

RECRUITING PHASE4

Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

NCT00544557

Ankylosing Spondylitis

COMPLETED

Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

NCT00434044

Ankylosing Spondylitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 methotrexate, salicylazosulfapyridine 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. Although the application of TNF alpha receptor inhibitor (such as Etanercept) has got the success in the early treatment of ankylosing spondylitis, the tolerance to this biological agent make the therapy to this disease rather difficult. Recently, owning to its immunoregulatory, immunosuppressive, stimulating hematopoiesis and tissue repairing properties, the infusion of human MSCs isolated from human bone marrow have been a promising and effective treatment to AS patients. This study will evaluate the safety and effectiveness of MSC transplantation in the AS patients and compare the efficiency with the Etanercept to treat AS patients.

This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant therapy (experimental group) or Etanercept therapy (control group). Patients will undergo MSC transplant at the start of the study on Day 0. The experimental group will receive infusion per week in the first 4 weeks and every two weeks in the second 8 weeks, totally for 12 weeks. After 3 months, patients will receive the second MSC transplantation. After 12 weeks (Phase I) and 48 weeks (Phase II) from the first transplantation, patients will be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spondylitis Spondylitis, Ankylosing Ankylosis Arthritis Spondylarthritis Spondylarthropathies Spinal Diseases Musculoskeletal Diseases Bone Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intravenous infusion of MSCs

Human bone marrow-derived MSCs at a dose of 1.0E+6 MSC/kg, receive infusion per week in the first 4 weeks and every two weeks in the second 8 weeks. total for 12 weeks.

Group Type EXPERIMENTAL

Intravenous infusion of MSCs

Intervention Type BIOLOGICAL

Intravenous infusion of MSCs:Human bone marrow-derived MSCs 1.0E+6 MSC/kg, IV drop

Etanercept

50mg,hypodermic injection,once per week, for 12 weeks

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

50mg,hypodermic injection,once per week, for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous infusion of MSCs

Intravenous infusion of MSCs:Human bone marrow-derived MSCs 1.0E+6 MSC/kg, IV drop

Intervention Type BIOLOGICAL

Etanercept

50mg,hypodermic injection,once per week, for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TNF alpha receptor inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No