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

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:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Edema Osteoarthritis

U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:

joint swelling [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Evaluation the swelling of hip joint after cell injection by physical examination.
deterioration of joint function [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
skin rash [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Evaluation the subchondral bone edema by MRI after cell transplantation.
cartilage thickness [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)

Estimated Enrollment:	6
Study Start Date:	March 2011
Estimated Study Completion Date:	August 2013
Estimated 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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500811

Contacts

Contact: Nasser Aghdami, MD,PhD	(+98)2122339913	nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD	(+98)2122339951	leila.arab@yahoo.com

Locations

Iran, Islamic Republic of
Royan Institute	Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD (+98)2122339913 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)2122339951 leila.arab@yahoo.com
Principal Investigator: Roghayeh Fazeli, MD
Sub-Investigator: Soura Mardpour, MSc
Sub-Investigator: Reza Moghadas Ali, MSc

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:	NCT01500811 History of Changes
Other Study ID Numbers:	Royan-Bone-009
Study First Received:	December 22, 2011
Last Updated:	December 25, 2012
Health Authority:	Iran: Ethics Committee Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013