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Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

NCT ID: NCT00813267

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Osteochondritis of the Femoral Head

Keywords

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Mesenchymal Stem Cells Osteonecrosis of the Femoral Head

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Group Type EXPERIMENTAL

mesenchymal stem cell infusion

Intervention Type BIOLOGICAL

bone marrow mononuclear cell infusion

Intervention Type BIOLOGICAL

Interventions

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mesenchymal stem cell infusion

Intervention Type BIOLOGICAL

bone marrow mononuclear cell infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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MSC infusion BMMNC infusion

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jianming Tan

OTHER

Sponsor Role lead

Responsible Party

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Jianming Tan

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jianming Tan, professor

Role: PRINCIPAL_INVESTIGATOR

Fuzhou General Hospital

Locations

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Fuzhou General Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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fuzhough1221

Identifier Type: -

Identifier Source: org_study_id