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

September 14, 2011
September 16, 2011
September 2010
September 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01436058 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis
Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Biological: mesenchymal stem cell
intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
Other Name: stem cell transplantation
Experimental: stem cell recipient
patients with ankle joint osteoarthritis
Intervention: Biological: mesenchymal stem cell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01436058
Royan-Bone-007
Yes
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
May 2010

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