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

Biostar Stem Cell Research Institute (R-Bio)

Status

Completed

Conditions

Avascular Necrosis of the Femoral Head

Treatments

Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01643655

KSC-MSCs-AVN

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.