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

NCT01643655 | Completed

• 1 other identifier: KSC-MSCs-AVN
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Avascular Necrosis of the Femoral Head

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• SPECT/CT

  96 weeks

• Hip X-ray

  96 weeks

• HHS (Harris Hip Score)

  96 weeks

• WOMAC (Western Ontario and McMaster Universities) Index

  96 weeks

• UCLA (University of California Los Angeles) hip questionnaire

  96 weeks

Study Arms (1)

Autologous Adipose Tissue Derived MSCs

EXPERIMENTAL

Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Interventions

Autologous Adipose Tissue derived MSCs Transplantation PROCEDURE

Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL

Autologous Adipose Tissue Derived MSCs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.

Sponsors & Collaborators

• R-Bio: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Femur Head Necrosis

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kang-Sup Yoon, M.D. & Ph.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

KR (1)