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

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

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.

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis of the Femoral Head
• Intervention / Treatment: Procedure: Autologous Adipose Tissue derived MSCs Transplantation

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging	To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.	96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPECT/CT	To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.	96 weeks
Hip X-ray	To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.	96 weeks
HHS (Harris Hip Score)	To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.	96 weeks
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.	96 weeks
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.	96 weeks
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.	96 weeks

Collaborators and Investigators

• Sponsor: R-Bio
• Collaborators: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Kang-Sup Yoon, M.D. & Ph.D., SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis; Femur Head Necrosis
• Other Study ID Numbers: KSC-MSCs-AVN