Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Jianming Tan

Status and phase

Unknown

Early Phase 1

Conditions

Osteochondritis of the Femoral Head

Treatments

Biological: mesenchymal stem cell infusion

Biological: bone marrow mononuclear cell infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00813267

fuzhough1221

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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.