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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643655
First Posted: July 18, 2012
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Biostar
  Purpose
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.

Condition Intervention
Avascular Necrosis of the Femoral Head Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head

Further study details as provided by Biostar:

Primary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: 96 weeks ]
    To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.


Secondary Outcome Measures:
  • SPECT/CT [ Time Frame: 96 weeks ]
    To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.

  • Hip X-ray [ Time Frame: 96 weeks ]
    To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.

  • HHS (Harris Hip Score) [ Time Frame: 96 weeks ]
    To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.

  • WOMAC (Western Ontario and McMaster Universities) Index [ Time Frame: 96 weeks ]
    To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.

  • UCLA (University of California Los Angeles) hip questionnaire [ Time Frame: 96 weeks ]
    To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.

  • Safety evaluation [ Time Frame: 96 weeks ]
    To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.


Enrollment: 15
Study Start Date: May 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Adipose Tissue Derived MSCs Procedure: Autologous Adipose Tissue derived MSCs Transplantation
Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age :18-70, males and females.
  • Subjects who understand and sign the consent form for this study.
  • Clinical diagnosis of nontraumatic avascular necrosis of the femoral head
  • Steinberg stage I, II, ⅢA
  • Patients whose lesion is more than 30% (by Kim's Method)

Exclusion Criteria:

  • Patients who have collapsed femoral head
  • Patient has had a Core Decompression or Multiple Drilling in the affected hip
  • Patients who received osteoporosis medicines and parathyroid hormone drugs
  • Taking medications that use the immunosuppressive drugs and cytotoxic agents or unable to discontinue their use for the duration of the study
  • Taking medications that use the adrenocortical hormone drugs or unable to discontinue their use for the duration of the study
  • Subject unable to undergo MRI (i.e. patients with pace-maker, metallic hip prosthetic implants)
  • Women who are pregnant or breast feeding or planning to become pregnant during the study.
  • Positive serology for HIV and hepatitis
  • Serious pre-existing medical conditions like Cardiovascular Diseases, Cancer, Renal Diseases, Endocrine Diseases and Autoimmune Diseases
  • Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643655


Locations
Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Biostar
SMG-SNU Boramae Medical Center
Investigators
Principal Investigator: Kang-Sup Yoon, M.D. & Ph.D. SMG-SNU Boramae Medical Center
  More Information

Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01643655     History of Changes
Other Study ID Numbers: KSC-MSCs-AVN
First Submitted: July 16, 2012
First Posted: July 18, 2012
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Femur Head Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases