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

Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Biological: cell injection

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chondrocyte; Patients with sever hip osteoarthritis who underwent intra articular cell injection.	Biological: cell injection; Intra articular injection of chondrocyte; Other Names: chondrocyte transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
joint swelling	Evaluation the swelling of hip joint after cell injection by physical examination.	2 months
deterioration of joint function	evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)	2 months
dispenea	Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.	1 week
skin rash	Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 months
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)	2 months
subchondral bone edema	Evaluation the subchondral bone edema by MRI after cell transplantation.	2 months
cartilage thickness	Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)	2 months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Principal Investigator: Mohsen Emadeddin, MD, Scientist

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 28, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: chondrocyte hip osteoarthritis intra articular injection
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: Royan-Bone-009