Overview

This trial is active, not recruiting.

Condition osteochondritis of the femoral head
Treatments mesenchymal stem cell infusion, bone marrow mononuclear cell infusion
Phase phase 0
Sponsor Jianming Tan
Start date December 2009
End date August 2011
Trial size 15 participants
Trial identifier NCT00813267, fuzhough1221

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
mesenchymal stem cell infusion MSC infusion
bone marrow mononuclear cell infusion BMMNC infusion

Primary Outcomes

Measure
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
time frame: 2

Secondary Outcomes

Measure
Coxa joint paining
time frame: 2
Walking distance
time frame: 2
Joint functions
time frame: 2
Life
time frame: 2

Eligibility Criteria

Male or female participants from 12 years up to 60 years old.

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.

Additional Information

Official title Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head
Principal investigator Jianming Tan, professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Fuzhou General Hospital.