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Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500811
First Posted: December 28, 2011
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  Purpose
Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.

Condition Intervention Phase
Hip Osteoarthritis Biological: cell injection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • joint swelling [ Time Frame: 2 months ]
    Evaluation the swelling of hip joint after cell injection by physical examination.

  • deterioration of joint function [ Time Frame: 2 months ]
    evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)

  • dispenea [ Time Frame: 1 week ]
    Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.

  • skin rash [ Time Frame: 1 week ]
    Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.


Secondary Outcome Measures:
  • Quantitative changes in pain intensity [ Time Frame: 2 months ]
    Evaluation the quantitative changes in pain measured by Visual Analogue Scale 2months after cell injection in compare with base line (before cell transplantation)

  • physical function improvement [ Time Frame: 2 months ]
    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score 2 months after cell injection in compare with base line(before cell transplantation)

  • subchondral bone edema [ Time Frame: 2 months ]
    Evaluation the subchondral bone edema by MRI after cell transplantation.

  • cartilage thickness [ Time Frame: 2 months ]
    Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)


Enrollment: 6
Study Start Date: March 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chondrocyte
Patients with sever hip osteoarthritis who underwent intra articular cell injection.
Biological: cell injection
Intra articular injection of chondrocyte
Other Name: chondrocyte transplantation

Detailed Description:
In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.
  Eligibility

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis diagnosed by MRI

Exclusion Criteria:

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500811


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Royan Cell therapy Center
Principal Investigator: Mohsen Emadeddin, MD scientist
  More Information

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01500811     History of Changes
Other Study ID Numbers: Royan-Bone-009
First Submitted: December 22, 2011
First Posted: December 28, 2011
Last Update Posted: April 28, 2014
Last Verified: January 2011

Keywords provided by Royan Institute:
chondrocyte hip osteoarthritis intra articular injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases