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Completed

NCT Number: NCT01643655

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

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.

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Key information

Conditions

Avascular Necrosis of the Femoral Head Bone Diseases Femur Head Necrosis Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Adipose Tissue derived MSCs Transplantation

Procedure

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

Primary outcomes

  1. Magnetic Resonance Imaging

    Time frame: 96 weeks

    To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.

Secondary outcomes

  1. SPECT/CT

    Time frame: 96 weeks

    To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.

  2. Hip X-ray

    Time frame: 96 weeks

    To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.

  3. HHS (Harris Hip Score)

    Time frame: 96 weeks

    To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.

  4. WOMAC (Western Ontario and McMaster Universities) Index

    Time frame: 96 weeks

    To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.

  5. UCLA (University of California Los Angeles) hip questionnaire

    Time frame: 96 weeks

    To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.

  6. Safety evaluation

    Time frame: 96 weeks

    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.

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 18, 2012
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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