- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813267
Mesenchymal Stem Cell for Osteonecrosis of the Femoral Head
October 6, 2012 updated by: Jianming Tan
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350025
- Fuzhou General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: stem cell
mesenchymal stem cell infusion and bone marrow mononuclear cell infusion
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
Time Frame: 2
|
2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Coxa joint paining
Time Frame: 2
|
2
|
Walking distance
Time Frame: 2
|
2
|
Joint functions
Time Frame: 2
|
2
|
Life
Time Frame: 2
|
2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianming Tan, professor, Fuzhou General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2011
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
December 21, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (Estimate)
December 23, 2008
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 6, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fuzhough1221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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