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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500811
• Other study ID #: Royan-Bone-009
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2011
• Last updated: April 24, 2014
• Start date: March 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2011
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Biological:
• cell injection
Intra articular injection of chondrocyte

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	joint swelling	Evaluation the swelling of hip joint after cell injection by physical examination.	2 months	Yes
Primary	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	Yes
Primary	dispenea	Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.	1 week	Yes
Primary	skin rash	Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.	1 week	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	subchondral bone edema	Evaluation the subchondral bone edema by MRI after cell transplantation.	2 months	Yes
Secondary	cartilage thickness	Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)	2 months	No