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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
Phase 1/Phase 2 trial testing Mesenchymal Stem Cells in Recovery Following Partial Medial Meniscectomy in 60 participants. Completed in 1 April 2008.
1 April 2008
Quick facts
| Lead sponsor | Mesoblast International Sàrl |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 September 2005 |
| Primary completion | 1 April 2008 |
| Estimated completion | 1 April 2008 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Mesenchymal Stem Cells — full drug profile →
- Hyaluronan — full drug profile →
Conditions studied
- Recovery Following Partial Medial Meniscectomy — all drugs for Recovery Following Partial Medial Meniscectomy →
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.
-
Meniscal Volume
Time frame: 6 months
Changes in meniscal volume over the course of the study as determined by MRI
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):
-
Progress in intra-articular therapy.
Evans CH, Kraus VB, Setton LA. · · 2014 · cited 425× · PMID 24189839 · DOI 10.1038/nrrheum.2013.159 -
Advances in regenerative orthopedics.
Evans CH. · · 2013 · cited 56× · PMID 24182709 · DOI 10.1016/j.mayocp.2013.04.027 -
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 -
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 -
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 -
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:
- PubMed search for NCT00225095
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Mesoblast International Sàrl trials
Trials by the same sponsor.
- NCT04456439 — Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome i · no longer available
- NCT04366830 — Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome · no longer available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00225095 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mesoblast International Sàrl
- Last refreshed: 23 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00225095.
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