Status:
COMPLETED
Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts
Lead Sponsor:
Stemform
Collaborating Sponsors:
Aleris-Hamlet Hospitaler København
Conditions:
Breast Hypoplasia and Facial Ageing
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly...
Detailed Description
The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects. The cosmetic facial filling design is a data assessor...
Eligibility Criteria
Inclusion
- Criteria breast augmentation:
- Inclusion criteria
- Age 18 - 50 years
- Healthy females
- BMI 18 - 30 kg/m2
- 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- Desire for breast augmentation
- Speaks and reads Danish or English
- Signed informed consent
- Exclusion criteria
- Smoking
- Previous breast surgery
- Previous cancer or predisposition to breast cancer
- Pregnancy or planned pregnancy within one year after the procedure
- Breastfeeding less than 6 months prior to inclusion
- Weight gain or loss above 2 BMI point
- Known chronic disease associated with metabolism malfunction or pour healing
- Pacemaker or other implanted foreign objects
- Allergy towards necessary anaesthesia
- Intention of weight loss or weight gain within the trial period
- Criteria fascial filling
- Inclusion criteria
- Age 25 - 65 years
- Healthy females
- BMI 18 - 30 kg/m2
- 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- Desire for facial wrinkle treatment and facial augmentation (rejuvenation)
- Speaks and reads Danish or English
- Signed informed consent
- Exclusion criteria
- Smoking
- Previous facial surgery
- Previous cancer
- Pregnancy or planned pregnancy within one year after the procedure
- Known chronic disease associated with metabolism malfunction or poor healing
- Allergy towards necessary anaesthesia
- Intention of weight loss or weight gain within the trial period
Exclusion
Key Trial Info
Start Date :
March 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03258164
Start Date
March 22 2017
End Date
November 22 2022
Last Update
November 28 2022
Active Locations (1)
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1
Stemform
Copenhagen, Søborg, Denmark, 2860