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Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mesenchymal Injection
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Mesenchymal cells, osteoarthritis, intra articular injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients not pregnant or lactating.
  • Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy
  • Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee.
  • Diagnosis must be based on magnetic resonance imaging.
  • Both genders
  • Age:18-65 years

Exclusion Criteria:

  • Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease.
  • Known allergic reaction to components of study treatment and/or study injection procedure
  • Patients infected with hepatitis B,C or HIV.

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal Injection

Arm Description

Intra Articular injection in Patients with osteoarthritis of knee joint

Outcomes

Primary Outcome Measures

Pain relief
evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain

Secondary Outcome Measures

Pain relief
decrease the patient pain in VAS scale

Full Information

First Posted
September 6, 2010
Last Updated
January 2, 2012
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01207661
Brief Title
Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint
Official Title
Mesenchymal Stem Cells Transplantation for Articular Cartilage Resurfacing in Patient With Osteoarthritis of Knee Joint
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Knee osteoarthritis is the most common form of arthritis. Treatments involve high costs in terms of social and economic, are palliative and do not contemplate healing by regenerative therapy. It has been shown recently, that mesenchymal stem cells (MSC) can be expanded in vitro and may regenerate several damaged or injured tissues. In addition its has demonstrated that MSC are able to modulate immune responses and to control inflammation through its action on T lymphocytes. Preliminary studies in animal models, including one carried out in an equine by the investigators research group, confirms feasibility, safety and efficacy evidence proposed treatment protocol.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.This study is designed to evaluate therapeutic potential and safety of mesenchymal stem cells in improvement of osteoarthritis clinical manifestations.
Detailed Description
Mesenchymal stem cells are pluripotent cells that can be obtained from various tissues .They have shown capabilities to differentiate into bone,cartilage,muscle,and adipose tissue, representing a new clinical strategy in regenerative medicine.An increasing number of reports have demonstrated effectiveness of percutaneous intra-articular infusion of MSCs in arthritic disease. In this study we perform a single intra articular injection of cultured mesenchymal stem cells in patients suffering from osteoarthritis, with the aim to assess its clinical safety and efficacy.Patients are assessed for response with MRI, X-Ray examination, WOMAC osteoarthritis index,VAS, and SF36 2,4,8 weeks and 6, and 12 months post infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Mesenchymal cells, osteoarthritis, intra articular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal Injection
Arm Type
Experimental
Arm Description
Intra Articular injection in Patients with osteoarthritis of knee joint
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Injection
Other Intervention Name(s)
Cell Injection
Intervention Description
Intra Articular Injection of Mesenchymal cells to the knee joint
Primary Outcome Measure Information:
Title
Pain relief
Description
evaluation the effect of Mesenchymal stem cell transplantation to decrease the patients pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain relief
Description
decrease the patient pain in VAS scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients not pregnant or lactating. Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior cell therapy Marcaine 0.75% و Lidocaine 4% test performed to be assure the exact location of the pain is related to the knee. Diagnosis must be based on magnetic resonance imaging. Both genders Age:18-65 years Exclusion Criteria: Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease. Known allergic reaction to components of study treatment and/or study injection procedure Patients infected with hepatitis B,C or HIV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammad reza Baghban Eslami Nejad, PhD
Organizational Affiliation
Scientific Board
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohssen Emadeddin, MD
Organizational Affiliation
Orthopadic Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Regeneration center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26058927
Citation
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.
Results Reference
derived
Links:
URL
http://www.royaninstitute.org
Description
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Articular Cartilage Resurfacing With Mesenchymal Stem Cells In Osteoarthritis Of Knee Joint

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