Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05079243
Other study ID # H-21004160
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 4, 2021
Est. completion date June 1, 2023

Study information

Verified date November 2022
Source Stemform
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.


Description:

The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date June 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - BMI between 18-30 kg/m2 - 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back - Desire for abdominoplasty - Speaks and reads Danish - Signed informed consent Exclusion Criteria: - Smoking - Previous major abdominal surgery - Previous cancer or predisposition to cancer - Pregnancy or planned pregnancy - Known chronic disease associated with metabolic malfunction or poor healing - Pacemaker - Allergy to necessary anaesthesia - Intention of significant weight loss or weight gain within the trial period

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Scaffold and adipose-derived stromal cell enriched fat grafts
eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer

Locations

Country Name City State
Denmark Aleris Hamlet Copenhagen Søborg
Denmark StemMedical Copenhagen Søborg

Sponsors (3)

Lead Sponsor Collaborator
Stemform Aleris-Hamlet Hospitaler København, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume assessment CT scan Baseline, three months, Six months
Secondary Cell count, immunohistochemistry, skin quality Cell count, immunohistochemistry, skin quality Three months, six months
Secondary Immunohistochemistry Immunohistochemistry Three months, six months
Secondary Skin thickness Skin thickness Three months, six months
See also
  Status Clinical Trial Phase
Terminated NCT02865928 - Serratus Plane Block for Postoperative Pain Control Phase 4
Active, not recruiting NCT03218969 - Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Phase 1/Phase 2
Completed NCT06280911 - The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy N/A
Not yet recruiting NCT05600608 - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome N/A
Withdrawn NCT00981266 - Spectra Breast Implant Study Phase 3
Recruiting NCT04266652 - Using the Roots of a Non Restorable Wisdom Tooth as a Block for Augmentation of Localized Defects Phase 4