Osteochondritis of the Femoral Head
Conditions
Keywords
Mesenchymal Stem Cells, Osteonecrosis of the Femoral Head
Brief summary
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.
Detailed description
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. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
Interventions
BIOLOGICALmesenchymal stem cell infusion
BIOLOGICALbone marrow mononuclear cell infusion
Sponsors
Jianming Tan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The femoral head blood-supply artery angiographies and the areas of femoral head necrosis | 2 |
Secondary
| Measure | Time frame |
|---|---|
| Coxa joint paining | 2 |
| Walking distance | 2 |
| Joint functions | 2 |
| Life | 2 |
Countries
China
Outcome results
None listed