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

Primary Purpose

Avascular Necrosis of the Femoral Head

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous Adipose Tissue derived MSCs Transplantation
Sponsored by
R-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avascular Necrosis of the Femoral Head

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Adipose Tissue Derived MSCs

Arm Description

Outcomes

Primary Outcome Measures

Magnetic Resonance Imaging
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
To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.
Hip X-ray
To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.
HHS (Harris Hip Score)
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
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
To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.
Safety evaluation
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.

Full Information

First Posted
July 16, 2012
Last Updated
August 30, 2017
Sponsor
R-Bio
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01643655
Brief Title
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
Official Title
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Avascular Necrosis of the Femoral Head
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of the Femoral Head

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Adipose Tissue Derived MSCs
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Intervention Description
Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Description
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
SPECT/CT
Description
To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.
Time Frame
96 weeks
Title
Hip X-ray
Description
To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.
Time Frame
96 weeks
Title
HHS (Harris Hip Score)
Description
To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.
Time Frame
96 weeks
Title
WOMAC (Western Ontario and McMaster Universities) Index
Description
To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.
Time Frame
96 weeks
Title
UCLA (University of California Los Angeles) hip questionnaire
Description
To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.
Time Frame
96 weeks
Title
Safety evaluation
Description
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.
Time Frame
96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang-Sup Yoon, M.D. & Ph.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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