NCT00702741

A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years

Completed Phase 1/Phase 2 Last updated 7 January 2022

What this trial tests

Phase 1/Phase 2 trial testing Chondrogen in Recovery Following Partial Medial Meniscectomy in 55 participants. Completed in 1 September 2011.

Timeline

1 June 2008

Primary endpoint
1 September 2011

1 September 2011

Quick facts

Lead sponsor	Mesoblast International Sàrl
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	55
Start date	1 June 2008
Primary completion	1 September 2011
Estimated completion	1 September 2011
Sites	4 locations across United States

Drugs / interventions tested

• Chondrogen — full drug profile →
• Chondrogen — full drug profile →
• Placebo

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.

• Comparison of treatment adverse event rates
  Time frame: Through 3 years

Sponsor's own description

The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).

Publications & conference data

7 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. Intra-articular delivery of purified mesenchymal stem cells from C57BL/6 or MRL/MpJ superhealer mice prevents posttraumatic arthritis.
   Diekman BO, Wu CL, Louer CR, Furman BD, et al · · 2013 · cited 95× · PMID 22889498 · DOI 10.3727/096368912x653264
3. Advances in regenerative orthopedics.
   Evans CH. · · 2013 · cited 56× · PMID 24182709 · DOI 10.1016/j.mayocp.2013.04.027
4. Mesenchymal Progenitor Cells and Their Orthopedic Applications: Forging a Path towards Clinical Trials.
   Shenaq DS, Rastegar F, Petkovic D, Zhang BQ, et al · · 2010 · cited 42× · PMID 21234334 · DOI 10.4061/2010/519028
5. The promise and challenges of stem cell-based therapies for skeletal diseases: stem cell applications in skeletal medicine: potential, cell sources and characteristics, and challenges of clinical translation.
   Diederichs S, Shine KM, Tuan RS. · · 2013 · cited 37× · PMID 22948900 · DOI 10.1002/bies.201200068
6. Potential clinical applications of adult human mesenchymal stem cell (Prochymal®) therapy.
   Patel AN, Genovese J. · · 2011 · cited 35× · PMID 24198531 · DOI 10.2147/sccaa.s11991
7. Clinical Replacement Strategies for Meniscus Tissue Deficiency.
   Wang D, Gonzalez-Leon E, Rodeo SA, Athanasiou KA. · · 2021 · cited 8× · PMID 34802295 · DOI 10.1177/19476035211060512