Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

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

Study Overview

• Status: Completed
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Biological: stem cell injection

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hip osteoarthritis; The patients with hip joint osteoarthritis who underwent cell injection	Biological: stem cell injection; intra articular inection of mesenchymal stem cell

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Principal Investigator: Mohsen Emadeddin, MD, Scientist

Publications and helpful links

General Publications

• Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 17, 2011
• First Submitted That Met QC Criteria: December 21, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): December 26, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: osteoarthritis; mesenchymal stem cell; hip joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: Royan-Bone-008