Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: mesenchymal stem cell

• Registration Number: NCT01436058
• Lead Sponsor: Royan Institute

Brief Summary

Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.

Detailed Description

In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-16
• Last Update Submitted: 2011-09-16
• Study First Posted: 2011-09-19
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

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

Inclusion Criteria

• Osteoarthritis diagnosed by MRI
• End stage osteoarthritis candidate for total ankle 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
stem cell recipient	mesenchymal stem cell	patients with ankle joint osteoarthritis

Primary Outcome Measures

Name	Time	Method
safety	6 months	Evaluate Safety of intra-articular injection of autologous cultured mesenchymal stem cells in patients with ankle osteoarthritis (time frame : baseline, 2 months, 6 months)by filling the check list of side effects

Secondary Outcome Measures

Name	Time	Method
pain	6 months	evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36
physical function	6 months	evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.
defect	6 months	evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect

Trial Locations

Locations (1)

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