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

NCT05079243 | Unknown

• 1 other identifier: H-21004160
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Augmentation; Reconstruction

Outcome Measures

Primary Outcomes (1)

• Volume assessment

  CT scan

  Baseline, three months, Six months

Secondary Outcomes (3)

• Cell count, immunohistochemistry, skin quality

  Three months, six months

• Immunohistochemistry

  Three months, six months

• Skin thickness

  Three months, six months

Study Arms (2)

Scaffold and adipose-derived stromal cell enriched fat grafts

EXPERIMENTAL

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

Biological: Scaffold and adipose-derived stromal cell enriched fat grafts

Controls samples

NO INTERVENTION

Control samples of untreated skin

Interventions

Scaffold and adipose-derived stromal cell enriched fat grafts BIOLOGICAL

eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer

Scaffold and adipose-derived stromal cell enriched fat grafts

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 18-30 kg/m2
• mL of fat (lipoaspirate) available for liposuction in the thighs or back
• Desire for abdominoplasty
• Speaks and reads Danish
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Stemform: lead
• Rigshospitalet, Denmark: collaborator
• Aleris-Hamlet Hospitaler København: collaborator

Study Sites (2)

Aleris Hamlet

Copenhagen, Søborg, 2860, Denmark

Location

StemMedical

Copenhagen, Søborg, 2860, Denmark

Location

Study Officials

• Frederik P Mamsen

  StemMedical A/S

  PRINCIPAL INVESTIGATOR

• stig-Frederik T Koelle, MD, PhD

  StemMedical A/S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Triple blinded, randomized, paired study on healthy participants

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: October 15, 2021
• Study Start: June 4, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)