Safety of Repaircell in Healthy Volunteers

Anterogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Repaircell

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739530

ANT-adip-AL-001

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Repaircell

Experimental group

Description:

allogenic differentiated adipocyte

Treatment:

Biological: Repaircell