Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702741

Enrollment

Registered

2008-06-20

Start date

2008-06-30

Completion date

2011-09-30

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery Following Partial Medial Meniscectomy

Keywords

Knee, Meniscus, Meniscectomy, Mesenchymal Stem Cells, MSCs, Adult Human Stem Cells, Osiris, Chondrogen

Brief summary

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).

Detailed description

The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.

Interventions

DRUGChondrogen

Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells

DRUGPlacebo

Intra-articular injection of Hyaluronan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Subject must have received an injection in Protocol No. 550 * Subject must have completed the 6-month and final 2-year visit in Protocol No. 550 * Subject must provide written informed consent for entry into the extension study * Subject must provide authorization for use and disclosure of protected health information for entry into the extension study

Design outcomes

Primary

Measure	Time frame
Comparison of treatment adverse event rates	Through 3 years

Secondary

Measure	Time frame
Concomitant Medications	Through 3 years
Visual Analog Scale	Through 3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026