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NCT00225095

A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years

Completed Phase 1/Phase 2 Last updated 23 December 2021
What this trial tests

Phase 1/Phase 2 trial testing Mesenchymal Stem Cells in Recovery Following Partial Medial Meniscectomy in 60 participants. Completed in 1 April 2008.

Timeline
1 September 2005
Primary endpoint
1 April 2008
1 April 2008

Quick facts

Lead sponsorMesoblast International Sàrl
PhasePhase 1/Phase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment60
Start date1 September 2005
Primary completion1 April 2008
Estimated completion1 April 2008
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mesoblast International Sàrl — full company profile →

Who can join

Adults 18 to 60, any sex, with Recovery Following Partial Medial Meniscectomy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Progress in intra-articular therapy.
    Evans CH, Kraus VB, Setton LA. · · 2014 · cited 425× · PMID 24189839 · DOI 10.1038/nrrheum.2013.159
  2. Advances in regenerative orthopedics.
    Evans CH. · · 2013 · cited 56× · PMID 24182709 · DOI 10.1016/j.mayocp.2013.04.027
  3. A systematic review of the concept and clinical applications of Bone Marrow Aspirate Concentrate in Orthopaedics.
    Imam MA, Mahmoud SSS, Holton J, Abouelmaati D, et al · · 2017 · cited 33× · PMID 29792397 · DOI 10.1051/sicotj/2017007
  4. Intra-articular injection choice for osteoarthritis: making sense of cell source-an updated systematic review and dual network meta-analysis.
    Zhang Y, Yang H, He F, Zhu X. · · 2022 · cited 28× · PMID 36443838 · DOI 10.1186/s13075-022-02953-0
  5. The Current Status of Clinical Trials on Biologics for Cartilage Repair and Osteoarthritis Treatment: An Analysis of ClinicalTrials.gov Data.
    Zhang Z, Schon L. · · 2022 · cited 21× · PMID 35546280 · DOI 10.1177/19476035221093065
  6. The Effectiveness and Safety of Mesenchymal Stem Cells in the Treatment of Osteoarthritis: A Systematic Review and Meta-analysis of 28 Randomized Controlled Trials.
    Long Z, Zhang M, Zhang T, Zeng L, et al · · 2022 · cited 6× · PMID 36277037 · DOI 10.1155/2022/6151866

Verify or expand the search:

Other trials of Mesenchymal Stem Cells

Trials testing the same drug.

Other Mesoblast International Sàrl trials

Trials by the same sponsor.

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Data sources for this page

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