Skip to main content
OpenTrials
Completed

NCT Number: NCT01739530

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repaircell

Biological

allogenic differentiated adipocyte

Primary outcomes

  1. Number of Adverse events

    Time frame: week 8

    Evaluate the safety at week 8 whether any kind of Adverse event occurs

Secondary outcomes

  1. Immunological response II

    Time frame: week 8

    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.

  2. Immunological response I

    Time frame: change from baseline CD4/CD8 ratio at week 8

    CD4 (cluster of differentiation 4)/CD8 (cluster of differentiation 8) ratio

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study title

Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2012
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.