Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499056
• Other study ID #: Royan-Bone-008
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2011
• Last updated: December 21, 2011
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Biological:
• stem cell injection
intra articular inection of mesenchymal stem cell

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	swelling of hip joint	Evaluatin the swelling of hip joint by physical examination after intra articular injection.	2 months	Yes
Primary	deterioration of joint function	Evaluation deterioration of joint function by physical examination after intra articular cell injection.	2 months	Yes
Primary	skin allergic reaction	Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.	1 week	Yes
Primary	Respiratory reaction	Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.	1 week	Yes
Secondary	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	Yes
Secondary	physical function improvement	Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.	2 months	Yes
Secondary	subchondral bone edema	Evaluation the subchondral bone edema by MRI	2 months	Yes
Secondary	cartilage thickness	measuring the cartilage thickness after cell transplantation by MRI	2 months	Yes