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

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ClinicalTrials.gov Identifier: NCT01436058
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE September 14, 2011
First Posted Date  ICMJE September 19, 2011
Last Update Posted Date September 19, 2011
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
  • pain [ Time Frame: 6 months ]
    evaluation the pain reduction in patients with ankle joint osteoarthritis after stem cell transplantation by filling the SF36
  • physical function [ Time Frame: 6 months ]
    evaluation the ability of patient to standing,walking,climb the steps after stem cell transplantation.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE Experimental: stem cell recipient
patients with ankle joint osteoarthritis
Intervention: Biological: mesenchymal stem cell
Publications * Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44. doi: 015186/AIM.003.

*   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
Actual Enrollment  ICMJE
 (submitted: September 16, 2011)
6
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Royan Institute
Verification Date May 2010

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