NCT01436058

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.

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 Sep 2010

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

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
Last Updated

September 19, 2011

Status Verified

May 1, 2010

Enrollment Period

1 year

First QC Date

September 14, 2011

Last Update Submit

September 16, 2011

Conditions

Osteoarthritis

Keywords

side effectmesenchymal stem cellankleosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • safety

    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

    6 months

Secondary Outcomes (3)

  • pain

    6 months

  • physical function

    6 months

  • defect

    6 months

Study Arms (1)

stem cell recipient

EXPERIMENTAL

patients with ankle joint osteoarthritis

Biological: mesenchymal stem cell

Interventions

mesenchymal stem cellBIOLOGICAL

intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis

Also known as: stem cell transplantation
stem cell recipient

Eligibility Criteria

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

You may qualify if:

  • Osteoarthritis diagnosed by MRI
  • End stage osteoarthritis candidate for total ankle replacement

You may not qualify if:

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder

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

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

    Head of Royan Cell therapy Center

    STUDY DIRECTOR

  • Mohsen Emadeddin, MD

    orthopedic scientists

    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 14, 2011

First Posted

September 19, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 19, 2011

Record last verified: 2010-05

Locations

IR(1)