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Clinical Trials/NCT00813267
NCT00813267UnknownEarly Phase 1

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

Jianming Tan1 site in 1 country15 target enrollmentStarted: December 2009Last updated:
Conditions

Trial Snapshot

Phase
Early Phase 1
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
12 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: 2

Secondary Outcomes

  • Coxa joint paining(2)
  • Walking distance(2)
  • Joint functions(2)
  • Life(2)

Investigators

Sponsor
Jianming Tan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jianming Tan

Director

Fuzhou General Hospital

Study Sites (1)

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