NCT00813267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2009

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

December 21, 2008

Last Update Submit

October 6, 2012

Conditions

Osteochondritis of the Femoral Head

Keywords

Mesenchymal Stem CellsOsteonecrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

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

    2

Secondary Outcomes (4)

  • Coxa joint paining

    2

  • Walking distance

    2

  • Joint functions

    2

  • Life

    2

Study Arms (1)

stem cell

EXPERIMENTAL

mesenchymal stem cell infusion and bone marrow mononuclear cell infusion

Biological: mesenchymal stem cell infusionBiological: bone marrow mononuclear cell infusion

Interventions

mesenchymal stem cell infusionBIOLOGICAL
Also known as: MSC infusion
stem cell
bone marrow mononuclear cell infusionBIOLOGICAL
Also known as: BMMNC infusion
stem cell

Eligibility Criteria

Age12 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jianming Tan, professor

    Fuzhou General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 21, 2008

First Posted

December 23, 2008

Study Start

December 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2015

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

CN(1)