Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Early Phase 1

• Conditions: Osteochondritis of the Femoral Head
• Interventions: Biological: mesenchymal stem cell infusion; Biological: bone marrow mononuclear cell infusion

• Registration Number: NCT00813267
• Lead Sponsor: Jianming Tan

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.

Study Timeline

• Study First Submitted: 2008-12-21
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Study Start: 2009-12
• Primary Completion: 2011-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-06
• Last Update Posted: 2012-10-10
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell	mesenchymal stem cell infusion	mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
stem cell	bone marrow mononuclear cell infusion	mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Primary Outcome Measures

Name	Time	Method
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis	2

Secondary Outcome Measures

Name	Time	Method
Coxa joint paining	2
Walking distance	2
Joint functions	2
Life	2

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China