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Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

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ClinicalTrials.gov Identifier: NCT00813267
Recruitment Status : Unknown
Verified October 2012 by Jianming Tan, Fuzhou General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2008
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
Jianming Tan, Fuzhou General Hospital

December 21, 2008
December 23, 2008
October 10, 2012
December 2009
August 2011   (Final data collection date for primary outcome measure)
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis [ Time Frame: 2 ]
Same as current
Complete list of historical versions of study NCT00813267 on ClinicalTrials.gov Archive Site
  • Coxa joint paining [ Time Frame: 2 ]
  • Walking distance [ Time Frame: 2 ]
  • Joint functions [ Time Frame: 2 ]
  • Life [ Time Frame: 2 ]
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head
Mesenchymal Stem Cell Transplantation in the Treatment of 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. 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.
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteochondritis of the Femoral Head
  • Biological: mesenchymal stem cell infusion
    Other Name: MSC infusion
  • Biological: bone marrow mononuclear cell infusion
    Other Name: BMMNC infusion
Experimental: stem cell
mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
Interventions:
  • Biological: mesenchymal stem cell infusion
  • Biological: bone marrow mononuclear cell infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
15
30
August 2015
August 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00813267
fuzhough1221
Yes
Not Provided
Not Provided
Jianming Tan, Fuzhou General Hospital
Jianming Tan
Not Provided
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
Fuzhou General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP