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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00813267
Other study ID # fuzhough1221
Secondary ID
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


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