Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 17, 2011
December 21, 2011
June 2010
February 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01499056 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hip Osteoarthritis
Biological: stem cell injection
intra articular inection of mesenchymal stem cell
Experimental: hip osteoarthritis
The patients with hip joint osteoarthritis who underwent cell injection
Intervention: Biological: stem cell injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01499056
Royan-Bone-008
Yes
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP