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

Royan Institute6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

mesenchymal stem cellBIOLOGICAL

intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Royan Institute

Tehran, Iran

Outcomes

Primary Outcomes

safety

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

Time frame: 6 months

Secondary Outcomes

pain

evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36

Time frame: 6 months

physical function

evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.

Time frame: 6 months

defect

evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect

Time frame: 6 months

Data from ClinicalTrials.gov

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