Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Osteochondritis of the Femoral Head Clinical Trial

Official title:

Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00813267
• Other study ID #: fuzhough1221
• Status: Active, not recruiting
• Phase: Phase 0
• First received: December 21, 2008
• Last updated: October 6, 2012
• Start date: December 2009
• Est. completion date: August 2015

Study information

• Verified date: October 2012
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteochondritis
• Osteochondritis of the Femoral Head
• Osteonecrosis

Intervention

Biological:
• mesenchymal stem cell infusion

• bone marrow mononuclear cell infusion

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Jianming Tan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The femoral head blood-supply artery angiographies and the areas of femoral head necrosis		2	No
Secondary	Coxa joint paining		2	No
Secondary	Walking distance		2	No
Secondary	Joint functions		2	No
Secondary	Life		2	No