Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar

Anterogen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depressed Scar

Treatments: Drug: Adipocell

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992147

ANTG-adip-301

Details and patient eligibility

About

Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• older than 19 years
• depressed scar less than volume of 5 ml
• negative for urine beta-HCG for women of childbearing age
• agreement to participate, with signed informed-consent

Exclusion criteria

• failure to meet inclusion criteria
• any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
• allergy to bovine-derived materials
• Diagnosis of cancer, AIDS, HBV or HCV.
• Patient has a lot of hairs or a tattoo on depressed site
• Insufficient adipose tissue for manufacturing of ANTG-adip
• Patient has depressed scar caused by a malignant tumor
• Patient whom investigator consider is not suitable in this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

autologous cultured adipocytes

Experimental group

Treatment:

Drug: Adipocell