Safety of Repaircell in Healthy Volunteers

NCT01739530 | Completed Phase 1

• 1 other identifier: ANT-adip-AL-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

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

  week 8

Secondary Outcomes (2)

• Immunological response II

  week 8

• Immunological response I

  change from baseline CD4/CD8 ratio at week 8

Study Arms (1)

Repaircell

EXPERIMENTAL

allogenic differentiated adipocyte

Biological: Repaircell

Interventions

Repaircell BIOLOGICAL

allogenic differentiated adipocyte

Repaircell

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

• Sa-ik Bang, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: December 3, 2012
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

KR (1)