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

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cell injection
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring chondrocyte hip osteoarthritis intra articular injection

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chondrocyte

Arm Description

Patients with sever hip osteoarthritis who underwent intra articular cell injection.

Outcomes

Primary Outcome Measures

joint swelling
Evaluation the swelling of hip joint after cell injection by physical examination.
deterioration of joint function
evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)
dispenea
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
skin rash
Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.

Secondary Outcome Measures

Quantitative changes in pain intensity
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
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
Evaluation the subchondral bone edema by MRI after cell transplantation.
cartilage thickness
Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)

Full Information

First Posted
December 22, 2011
Last Updated
April 24, 2014
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01500811
Brief Title
Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Official Title
Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
chondrocyte hip osteoarthritis intra articular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chondrocyte
Arm Type
Experimental
Arm Description
Patients with sever hip osteoarthritis who underwent intra articular cell injection.
Intervention Type
Biological
Intervention Name(s)
cell injection
Other Intervention Name(s)
chondrocyte transplantation
Intervention Description
Intra articular injection of chondrocyte
Primary Outcome Measure Information:
Title
joint swelling
Description
Evaluation the swelling of hip joint after cell injection by physical examination.
Time Frame
2 months
Title
deterioration of joint function
Description
evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)
Time Frame
2 months
Title
dispenea
Description
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
Time Frame
1 week
Title
skin rash
Description
Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Quantitative changes in pain intensity
Description
Evaluation the quantitative changes in pain measured by Visual Analogue Scale 2months after cell injection in compare with base line (before cell transplantation)
Time Frame
2 months
Title
physical function improvement
Description
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)
Time Frame
2 months
Title
subchondral bone edema
Description
Evaluation the subchondral bone edema by MRI after cell transplantation.
Time Frame
2 months
Title
cartilage thickness
Description
Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Royan Cell therapy Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emadeddin, MD
Organizational Affiliation
scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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