Safety of Repaircell in Healthy Volunteers | NCT01739530

Studies
Safety of Repaircell in Healthy Volunteers

NCT01739530

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Dec 4, 2012Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Repaircell

Countries

South Korea

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

Dec 2012

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

Mar 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 29, 2012

First Posted Date

Dec 3, 2012Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2012

Last Update Posted Date

Dec 4, 2012Estimated

Description Module

Brief Summary

Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Label	Type	Description	Intervention Names
Repaircell	Experimental	allogenic differentiated adipocyte	Biological: Repaircell

Name	Type	Description	Arm Group Labels	Other Names
Repaircell	Biological	allogenic differentiated adipocyte	Repaircell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Adverse events	Evaluate the safety at week 8 whether any kind of Adverse event occurs	week 8

Secondary Outcomes

Measure	Description	Time Frame
Immunological response II	Infiltration of immune cells by histology based on five basic parameters: (0) No evidence of immune cell infiltration in all area of the tissue, (1) Slight immune cell infiltration visible in partial area of the tissue (barely visible), (2) Obvious immune cell infiltration visible in partial area of the tissue, (3) Slight immune cell infiltration visible in all area of the tissue, and (4) Intense immune cell infiltration visible in all areas of the tissue.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male, 19 years of age or older
volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
informed consent form signed

Exclusion Criteria:

volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
volunteers who have tattoo or scar which disturb assessment of study at injection site
volunteers who have Creutzfeldt Jacobs disease or related disease or family history
volunteers who have allergy to bovine-derived materials
volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
volunteers who have a clinically relevant history of abuse of alcohol or drugs
volunteers who are considered not suitable for the study by investigator
volunteers who have history of surgery for malignant cancer in the past 5 years
volunteers who have congenital or acquired immunodeficiency syndrome
volunteers who have horrible anemia or thrombopenia
volunteers who have chronic disease such cardiovascular,renal and respirometer disease
volunteers who were immunosuppressed by disease (ex: chronic heart failure)
volunteers who were immunodepressed by treatment of medication
volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
volunteers who have abnormal rage of CD4/CD8 ratio

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided