Augmentation Clinical Trial
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
Verified date | November 2022 |
Source | Stemform |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aleris Hamlet | Copenhagen | Søborg |
Denmark | StemMedical | Copenhagen | Søborg |
Lead Sponsor | Collaborator |
---|---|
Stemform | Aleris-Hamlet Hospitaler København, Rigshospitalet, Denmark |
Denmark,
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 |
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