Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

Phase 1

Completed

• Conditions: Hip Osteoarthritis
• Interventions: Biological: stem cell injection

• Registration Number: NCT01499056
• Lead Sponsor: Royan Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-06
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Study First Submitted: 2011-12-17
• Study First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Study First Posted: 2011-12-26
• Last Update Posted: 2011-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hip osteoarthritis	stem cell injection	The patients with hip joint osteoarthritis who underwent cell injection

Primary Outcome Measures

Name	Time	Method
swelling of hip joint	2 months	Evaluatin the swelling of hip joint by physical examination after intra articular injection.
deterioration of joint function	2 months	Evaluation deterioration of joint function by physical examination after intra articular cell injection.
skin allergic reaction	1 week	Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Respiratory reaction	1 week	Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.

Secondary Outcome Measures

Name	Time	Method
cartilage thickness	2 months	measuring the cartilage thickness after cell transplantation by MRI
Quantitative changes in pain intensity	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)
physical function improvement	2 months	Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
subchondral bone edema	2 months	Evaluation the subchondral bone edema by MRI

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of