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

NCT ID: NCT01643655

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Avascular Necrosis of the Femoral Head

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Adipose Tissue Derived MSCs

Group Type EXPERIMENTAL

Autologous Adipose Tissue derived MSCs Transplantation

Intervention Type PROCEDURE

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

Interventions

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Autologous Adipose Tissue derived MSCs Transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

R-Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kang-Sup Yoon, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KSC-MSCs-AVN

Identifier Type: -

Identifier Source: org_study_id

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