Osteochondritis of the Femoral Head Clinical Trial
Official title:
Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head
Verified date | October 2012 |
Source | Fuzhou General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | August 2015 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Ages: 12 to 60 years old. - Association Research Circulation Osseous(ARCO) Classification criteria for osteonecrosis of the femoral head: ARCO phase I and phase II. - Able to give informed consent. Exclusion Criteria: - Pregnant women. - Previous history of malignancy - Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. - Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in the past 6 months. - Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible. - Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Fuzhou General Hospital | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Jianming Tan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The femoral head blood-supply artery angiographies and the areas of femoral head necrosis | 2 | No | |
Secondary | Coxa joint paining | 2 | No | |
Secondary | Walking distance | 2 | No | |
Secondary | Joint functions | 2 | No | |
Secondary | Life | 2 | No |