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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:
NCT01643655
First received: July 16, 2012
Last updated: February 28, 2013
Last verified: July 2012
History of Changes
  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 Phase
Avascular Necrosis of the Femoral Head
 Procedure: Autologous Adipose Tissue derived MSCs Transplantation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 RNL Bio Company Ltd.:

Primary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643655

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

No publications provided

Responsible Party: RNL Bio Company Ltd.
ClinicalTrials.gov Identifier: NCT01643655     History of Changes
Other Study ID Numbers: RB-MSCs-AVN
Study First Received: July 16, 2012
Last Updated: February 28, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013