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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01436058
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: mesenchymal stem cell Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Patients With Ankle Joint Osteoarteritis
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: stem cell recipient
patients with ankle joint osteoarthritis
Biological: mesenchymal stem cell
intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
Other Name: stem cell transplantation

Primary Outcome Measures :
  1. safety [ Time Frame: 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 :
  1. pain [ Time Frame: 6 months ]
    evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36

  2. physical function [ Time Frame: 6 months ]
    evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.

  3. defect [ Time Frame: 6 months ]
    evaluation regeneration of ankle joint by serial MRI after stem cell transplantation based on changing the size of articular defect

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01436058

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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
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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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Royan Institute Identifier: NCT01436058    
Other Study ID Numbers: Royan-Bone-007
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: May 2010
Keywords provided by Royan Institute:
side effect
mesenchymal stem cell
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases