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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressed Scar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous cultured adipocytes

Group Type EXPERIMENTAL

Adipocell

Intervention Type DRUG

autologous cultured adipocytes (ANTG-adip)

Interventions

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Adipocell

autologous cultured adipocytes (ANTG-adip)

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No