Clinical trial NCT00813267: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Osteochondritis of the Femoral Head
Keywords: Mesenchymal Stem Cells
Osteonecrosis of the Femoral Head
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The femoral head blood-supply artery angiographies and the areas of femoral head necrosis
timeFrame: 2
Secondary outcomes:
measure: Coxa joint paining
timeFrame: 2
measure: Walking distance
timeFrame: 2
measure: Joint functions
timeFrame: 2
measure: Life
timeFrame: 2
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
affiliation: Fuzhou General Hospital
name: Jianming Tan, professor
role: PRINCIPAL_INVESTIGATOR
References: