NCT00702741

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2008

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

June 19, 2008

Last Update Submit

January 7, 2022

Conditions

Recovery Following Partial Medial Meniscectomy

Keywords

KneeMeniscusMeniscectomyMesenchymal Stem CellsMSCsAdult Human Stem CellsOsirisChondrogen

Outcome Measures

Primary Outcomes (1)

  • Comparison of treatment adverse event rates

    Through 3 years

Secondary Outcomes (2)

  • Concomitant Medications

    Through 3 years

  • Visual Analog Scale

    Through 3 years

Study Arms (3)

A

EXPERIMENTAL

Chondrogen (low dose)

Drug: Chondrogen

B

EXPERIMENTAL

Chondrogen (high dose)

Drug: Chondrogen

C

PLACEBO COMPARATOR

Hyaluronan

Drug: Placebo

Interventions

ChondrogenDRUG

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

A
PlaceboDRUG

Intra-articular injection of Hyaluronan

C

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Southern California Keck School of Medicine

Los Angeles, California, United States

Location

OrthoIndy

Indianapolis, Indiana, United States

Location

TRIA Orthopaedic Center

Bloomington, Minnesota, United States

Location

Unlimited Research

San Antonio, Texas, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

US(4)