Safety of Repaircell in Healthy Volunteers

Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Repaircell

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repaircell; allogenic differentiated adipocyte	Biological: Repaircell; allogenic differentiated adipocyte

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	week 8
Immunological response I	CD4 (cluster of differentiation 4)/CD8 (cluster of differentiation 8) ratio	change from baseline CD4/CD8 ratio at week 8

Collaborators and Investigators

• Sponsor: Anterogen Co., Ltd.
• Investigators: Principal Investigator: Sa-ik Bang, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: ANT-adip-AL-001