Trial | NCT00813267  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    15
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.
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 Started
Dec 31
2009
Primary Completion
Aug 31
2011
Study Completion
Aug 31
2015
Anticipated
Last Update
Oct 10
2012
Estimate

Biological mesenchymal stem cell infusion

  • Other names: MSC infusion

Biological bone marrow mononuclear cell infusion

  • Other names: BMMNC infusion

stem cell Experimental

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

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.
No Results Posted