NCT00850187

Brief Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis

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 knee-osteoarthritis

Timeline
Completed

Started Aug 2008

Typical duration for phase_1 knee-osteoarthritis

Geographic Reach
1 country

2 active sites

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, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

April 1, 2010

Enrollment Period

1.9 years

First QC Date

February 21, 2009

Last Update Submit

January 2, 2012

Conditions

Knee Osteoarthritis

Keywords

Knee cartilage diseases

Outcome Measures

Primary Outcomes (1)

  • Knee cartilage defects

    12 months

Secondary Outcomes (1)

  • pain

    12 months

Study Arms (1)

Bone marrow mesenchymal stem cells

EXPERIMENTAL
Biological: Bone marrow derived mesenchymal stem cells

Interventions

Bone marrow derived mesenchymal stem cellsBIOLOGICAL

Bone Marrow Aspiration A total volume of 300 ml bone marrow will be aspirated from the iliac crest and are cultured for mesenchymal stem cells

Bone marrow mesenchymal stem cells

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 45 to 60, inclusive
  • Normal axial alignment
  • Stable knee-previous ligament reconstruction, if stable
  • Intact articular cartilage in posterior meniscal weight-bearing zone
  • Ability to understand and willingness tosign consent from
  • O.C.D or OA calgran classification II,III

You may not qualify if:

  • Pregnant or lactating
  • Inflammatory arthritis
  • Oral steriod, methotrexate
  • Unable to follow post-operative exercise regimen or return for evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royan Institute

Tehran, Tehran Province, Iran

Location

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hamid gourabi, PhD

    Chief

    STUDY CHAIR

  • Mohamadreza Baghaban Eslaminejad, PhD

    Scientific Board

    STUDY DIRECTOR

  • Leila Taghiyar, Msc

    Researcher

    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

February 21, 2009

First Posted

February 24, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

January 5, 2012

Record last verified: 2010-04

Locations

IR(2)