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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Royan Institute

ClinicalTrials.gov Identifier:

NCT01436058

First received: September 14, 2011

Last updated: September 16, 2011

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2011

Last Updated Date

September 16, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01436058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36
physical function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.
defect [ Time Frame: 6 months ] [ Designated as safety issue: No ]
evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Biological: mesenchymal stem cell

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

Other Name: stem cell transplantation

Study Arm (s)

Experimental: stem cell recipient

patients with ankle joint osteoarthritis

Intervention: Biological: mesenchymal stem cell

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Iran, Islamic Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01436058

Other Study ID Numbers ^ICMJE

Royan-Bone-007

Has Data Monitoring Committee

Yes

Responsible Party

Royan Institute

Study Sponsor ^ICMJE

Royan Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Hamid Gourabi, PhD	Head of Royan Institute
Study Director:	Nasser Aghdami, MD,PhD	Head of Royan Cell therapy Center
Principal Investigator:	Mohsen Emadeddin, MD	orthopedic scientists

Information Provided By

Royan Institute

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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