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

Sponsored by R-Bio

About this trial

Last updated 9 years ago

Study ID

KSC-MSCs-AVN

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 70 Years
All Sexes

Trial Timing

Ended 11 years ago

What is this trial 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.

What are the participation requirements?

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.