Safety of Repaircell in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01739530
First received: November 15, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: Repaircell
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers

Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:
  • Number of Adverse events [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    Evaluate the safety at week 8 whether any kind of Adverse event occurs


Secondary Outcome Measures:
  • Immunological response II [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    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.

  • Immunological response I [ Time Frame: change from baseline CD4/CD8 ratio at week 8 ] [ Designated as safety issue: Yes ]
    CD4 (cluster of differentiation 4)/CD8 (cluster of differentiation 8) ratio


Enrollment: 5
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repaircell
allogenic differentiated adipocyte
Biological: Repaircell
allogenic differentiated adipocyte
Other Name: Repaircell

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739530

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
Principal Investigator: Sa-ik Bang, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT01739530     History of Changes
Other Study ID Numbers: ANT-adip-AL-001
Study First Received: November 15, 2012
Last Updated: December 3, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on July 23, 2014