Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

This study has been completed.

Sponsor:

Information provided by:

Sewon Cellontech Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01050816

First received: January 13, 2010

Last updated: May 6, 2010

Last verified: May 2010

History of Changes

Results First Received: January 21, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Articular Cartilage Defects of Ankle Joint
Intervention:	Procedure: Chondron(autologous chondrocyte) Implantation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
30 subjects who have ankle cartilage defects

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Chondron Implantation	Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.

Participant Flow: Overall Study

	Chondron Implantation
STARTED	30
COMPLETED	26
NOT COMPLETED	4
Lost to Follow-up	2
patient's refusal	2

Baseline Characteristics

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Reporting Groups

	Description
Chondron Implantation	Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.

Baseline Measures

	Chondron Implantation
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	0
Age [units: years] Mean ± Standard Deviation	36.67 ± 11.44
Gender [units: participants]
Female	4
Male	26
Region of Enrollment [units: participants]
Korea, Republic of	30

Outcome Measures

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1. Primary:

Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]

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2. Secondary:

Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]

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3. Secondary:

Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery [ Time Frame: baseline(preoperative stage),12months post-surgery ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Lee Gyeong Tae
Organization: Eulji General Hospital
phone: +82-11-214-3323
e-mail: lkt2408@hanmail.net

No publications provided

Responsible Party:	Gyeong Tea , Lee, Eulji General Hospital
ClinicalTrials.gov Identifier:	NCT01050816 History of Changes
Other Study ID Numbers:	02CON
Study First Received:	January 13, 2010
Results First Received:	January 21, 2010
Last Updated:	May 6, 2010
Health Authority:	Korea: Food and Drug Administration

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