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Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections

Sponsor
Stemform (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05079243
Collaborator
Rigshospitalet, Denmark (Other), Aleris-Hamlet Hospitaler København (Other)
5
Enrollment
2
Locations
2
Arms
23.9
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Scaffold and adipose-derived stromal cell enriched fat grafts
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Triple blinded, randomized, paired study on healthy participantsTriple blinded, randomized, paired study on healthy participants
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds
Actual Study Start Date :
Jun 4, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Scaffold and adipose-derived stromal cell enriched fat grafts

Randomized and paired injections. Each participant will receive all 11 solutions.

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
No Intervention: Controls samples

Control samples of untreated skin

Outcome Measures

Primary Outcome Measures

  1. Volume assessment [Baseline, three months, Six months]

    CT scan

Secondary Outcome Measures

  1. Cell count, immunohistochemistry, skin quality [Three months, six months]

    Cell count, immunohistochemistry, skin quality

  2. Immunohistochemistry [Three months, six months]

    Immunohistochemistry

  3. Skin thickness [Three months, six months]

    Skin thickness

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aleris Hamlet Copenhagen Søborg Denmark 2860
2 StemMedical Copenhagen Søborg Denmark 2860

Sponsors and Collaborators

  • Stemform
  • Rigshospitalet, Denmark
  • Aleris-Hamlet Hospitaler København

Investigators

  • Principal Investigator: Frederik P Mamsen, StemMedical
  • Principal Investigator: stig-Frederik T Koelle, MD, PhD, StemMedical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stemform
ClinicalTrials.gov Identifier:
NCT05079243
Other Study ID Numbers:
  • H-21004160
First Posted:
Oct 15, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 15, 2021