Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jianming Tan, Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT00813267
First received: December 21, 2008
Last updated: October 6, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Osteochondritis of the Femoral Head
Biological: mesenchymal stem cell infusion
Biological: bone marrow mononuclear cell infusion
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Transplantation in the Treatment of Osteonecrosis of the Femoral Head

Resource links provided by NLM:


Further study details as provided by Fuzhou General Hospital:

Primary Outcome Measures:
  • The femoral head blood-supply artery angiographies and the areas of femoral head necrosis [ Time Frame: 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coxa joint paining [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Walking distance [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Joint functions [ Time Frame: 2 ] [ Designated as safety issue: No ]
  • Life [ Time Frame: 2 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stem cell
mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
Biological: mesenchymal stem cell infusion
Other Name: MSC infusion
Biological: bone marrow mononuclear cell infusion
Other Name: BMMNC infusion

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813267

Locations
China, Fujian
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Jianming Tan
Investigators
Principal Investigator: Jianming Tan, professor Fuzhou General Hospital
  More Information

No publications provided

Responsible Party: Jianming Tan, Director, Fuzhou General Hospital
ClinicalTrials.gov Identifier: NCT00813267     History of Changes
Other Study ID Numbers: fuzhough1221
Study First Received: December 21, 2008
Last Updated: October 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Fuzhou General Hospital:
Mesenchymal Stem Cells
Osteonecrosis of the Femoral Head

Additional relevant MeSH terms:
Osteochondritis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014