UnknownEarly Phase 1

Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

China15 participantsStarted 2009-12

Plain-language 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.

Who can participate

Age range12 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The femoral head blood-supply artery angiographies and the areas of femoral head necrosis

Timeframe: 2

Trial details

NCT IDNCT00813267

SponsorJianming Tan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Osteochondritis of the Femoral Head trials