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Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Primary Purpose

Osteochondritis of the Femoral Head

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

mesenchymal stem cell infusion

bone marrow mononuclear cell infusion

About this trial

This is an interventional treatment trial for Osteochondritis of the Femoral Head focused on measuring Mesenchymal Stem Cells, Osteonecrosis of the Femoral Head

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fuzhou General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell

Arm Description

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Coxa joint paining

Walking distance

Joint functions

Life

Full Information

NCT ID

NCT00813267

First Posted

December 21, 2008

Last Updated

October 6, 2012

Sponsor

Jianming Tan

1. Study Identification

Unique Protocol Identification Number

NCT00813267

Brief Title

Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jianming Tan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteochondritis of the Femoral Head

Keywords

Mesenchymal Stem Cells, Osteonecrosis of the Femoral Head

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stem cell

Arm Type

Experimental

Arm Description

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Intervention Type

Biological

Intervention Name(s)

mesenchymal stem cell infusion

Other Intervention Name(s)

MSC infusion

Intervention Type

Biological

Intervention Name(s)

bone marrow mononuclear cell infusion

Other Intervention Name(s)

BMMNC infusion

Primary Outcome Measure Information:

Title

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

Time Frame

Secondary Outcome Measure Information:

Title

Coxa joint paining

Time Frame

Title

Walking distance

Time Frame

Title

Joint functions

Time Frame

Title

Life

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianming Tan, professor

Organizational Affiliation

Fuzhou General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuzhou General Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350025

Country

China

12. IPD Sharing Statement

Learn more about this trial

Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head

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