Follow-up Study of Chondrogen® Delivered by Intra-Articul... | NCT00702741

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

NCT00702741

Sponsor

Mesoblast International Sàrl

Status

Completed

Last Update Posted

Jan 11, 2022Actual

Enrollment

55Actual

Phase

Phase 1Phase 2

Conditions

Recovery Following Partial Medial Meniscectomy

Interventions

Chondrogen
Chondrogen
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 19, 2008

First Submission Date that Met QC Criteria

Jun 19, 2008

First Posted Date

Jun 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 23, 2021

Certification/Extension First Submitted that Passed QC Review

Jan 7, 2022

Certification/Extension First Posted Date

Jan 11, 2022Actual

Last Update Submitted Date

Jan 7, 2022

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Chondrogen (low dose)	Drug: Chondrogen
B	Experimental	Chondrogen (high dose)	Drug: Chondrogen
C	Placebo Comparator	Hyaluronan	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chondrogen	Drug	Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of treatment adverse event rates		Through 3 years

Secondary Outcomes

Measure	Description	Time Frame
Concomitant Medications		Through 3 years
Visual Analog Scale		Through 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California Keck School of Medicine		Los Angeles	California		United States