Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01499056
First received: December 17, 2011
Last updated: December 21, 2011
Last verified: January 2010
  Purpose

Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis


Condition Intervention Phase
Hip Osteoarthritis
Biological: stem cell injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • swelling of hip joint [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Evaluatin the swelling of hip joint by physical examination after intra articular injection.

  • deterioration of joint function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Evaluation deterioration of joint function by physical examination after intra articular cell injection.

  • skin allergic reaction [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.

  • Respiratory reaction [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.


Secondary Outcome Measures:
  • Quantitative changes in pain intensity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)

  • physical function improvement [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.

  • subchondral bone edema [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Evaluation the subchondral bone edema by MRI

  • cartilage thickness [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    measuring the cartilage thickness after cell transplantation by MRI


Enrollment: 6
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hip osteoarthritis
The patients with hip joint osteoarthritis who underwent cell injection
Biological: stem cell injection
intra articular inection of mesenchymal stem cell

Detailed Description:

This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis diagnosed by MRI
  • End stage osteoarthritis candidate for total hip replacement

Exclusion Criteria:

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499056

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

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01499056     History of Changes
Other Study ID Numbers: Royan-Bone-008
Study First Received: December 17, 2011
Last Updated: December 21, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
osteoarthritis
hip joint
mesenchymal stem cell

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

ClinicalTrials.gov processed this record on July 20, 2014