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NCT Number: NCT01500811

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cell injection

Biological

Intra articular injection of chondrocyte

Other names: chondrocyte transplantation

Primary outcomes

  1. joint swelling

    Time frame: 2 months

    Evaluation the swelling of hip joint after cell injection by physical examination.

  2. deterioration of joint function

    Time frame: 2 months

    evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)

  3. dispenea

    Time frame: 1 week

    Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.

  4. skin rash

    Time frame: 1 week

    Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.

Secondary outcomes

  1. Quantitative changes in pain intensity

    Time frame: 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)

  2. physical function improvement

    Time frame: 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)

  3. subchondral bone edema

    Time frame: 2 months

    Evaluation the subchondral bone edema by MRI after cell transplantation.

  4. cartilage thickness

    Time frame: 2 months

    Evaluation the cartilage thickness by MRI after cell injection in compare with baseline (before cell injection)

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2011
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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