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Completed

NCT Number: NCT01499056

Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoarthritis diagnosed by MRI
  • End stage osteoarthritis candidate for total hip replacement

Exclusion criteria

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder

Treatment and study plan

stem cell injection

Biological

intra articular inection of mesenchymal stem cell

Primary outcomes

  1. swelling of hip joint

    Time frame: 2 months

    Evaluatin the swelling of hip joint by physical examination after intra articular injection.

  2. deterioration of joint function

    Time frame: 2 months

    Evaluation deterioration of joint function by physical examination after intra articular cell injection.

  3. skin allergic reaction

    Time frame: 1 week

    Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.

  4. Respiratory reaction

    Time frame: 1 week

    Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.

Secondary outcomes

  1. Quantitative changes in pain intensity

    Time frame: 2 months

    Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)

  2. physical function improvement

    Time frame: 2 months

    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.

  3. subchondral bone edema

    Time frame: 2 months

    Evaluation the subchondral bone edema by MRI

  4. cartilage thickness

    Time frame: 2 months

    measuring the cartilage thickness after cell transplantation by MRI

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 26, 2011
Registry last updated
Dec 26, 2011

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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