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

Avascular Necrosis of the Femoral Head Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643655
• Other study ID #: KSC-MSCs-AVN
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: August 30, 2017
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: August 2017
• Source: Biostar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, ?A

• 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.

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Head
• Femur Head Necrosis
• Necrosis
• Osteonecrosis

Intervention

Procedure:
• Autologous Adipose Tissue derived MSCs Transplantation
Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Biostar	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SPECT/CT	To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.	96 weeks
Secondary	Hip X-ray	To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.	96 weeks
Secondary	HHS (Harris Hip Score)	To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.	96 weeks
Secondary	WOMAC (Western Ontario and McMaster Universities) Index	To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.	96 weeks
Secondary	UCLA (University of California Los Angeles) hip questionnaire	To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.	96 weeks
Secondary	Safety evaluation	To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.	96 weeks