NCT01207661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

September 6, 2010

Last Update Submit

January 2, 2012

Conditions

Osteoarthritis

Keywords

Mesenchymal cellsosteoarthritisintra articular injection

Outcome Measures

Primary Outcomes (1)

  • Pain relief

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

    6 months

Secondary Outcomes (1)

  • Pain relief

    6 months

Study Arms (1)

Mesenchymal Injection

EXPERIMENTAL

Intra Articular injection in Patients with osteoarthritis of knee joint

Biological: Mesenchymal Injection

Interventions

Mesenchymal InjectionBIOLOGICAL

Intra Articular Injection of Mesenchymal cells to the knee joint

Also known as: Cell Injection
Mesenchymal Injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 26058927DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Mohammad reza Baghban Eslami Nejad, PhD

    Scientific Board

    STUDY DIRECTOR

  • Mohssen Emadeddin, MD

    Orthopadic Investigator

    PRINCIPAL INVESTIGATOR

  • Nasser Aghdami, MD,PhD

    Head of Regeneration center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2010

First Posted

September 23, 2010

Study Start

August 1, 2009

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

January 5, 2012

Record last verified: 2009-04

Locations

IR(1)