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
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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COMPLETED
NA
15 participants
INTERVENTIONAL
2012-05-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous Adipose Tissue Derived MSCs
Autologous Adipose Tissue derived MSCs Transplantation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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SMG-SNU Boramae Medical Center
OTHER
R-Bio
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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KSC-MSCs-AVN
Identifier Type: -
Identifier Source: org_study_id
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