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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01500811

Enrollment

Registered

2011-12-28

Start date

2011-03-31

Completion date

2013-08-31

Last updated

2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

Keywords

chondrocyte hip osteoarthritis intra articular injection

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.

Interventions

BIOLOGICALcell injection

Intra articular injection of chondrocyte

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Quantitative changes in pain intensity	2 months	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	2 months	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	2 months	Evaluation the subchondral bone edema by MRI after cell transplantation.
cartilage thickness	2 months	Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026