Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

NCT ID: NCT00813267

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Osteochondritis of the Femoral Head

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stem cell

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Group Type: EXPERIMENTAL

mesenchymal stem cell infusion

Intervention Type: BIOLOGICAL

bone marrow mononuclear cell infusion

Intervention Type: BIOLOGICAL

Interventions

mesenchymal stem cell infusion

Intervention Type: BIOLOGICAL

bone marrow mononuclear cell infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

MSC infusion; BMMNC infusion

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianming Tan

OTHER

Sponsor Role: lead

Responsible Party

Jianming Tan

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jianming Tan, professor

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital

Locations

Fuzhou General Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

fuzhough1221

Identifier Type: -

Identifier Source: org_study_id