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Clinical trial

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

ID
Name
H-21004160
Description
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.
Trial arms
Trial start
2021-06-04
Estimated PCD
2022-12-01
Trial end
2023-06-01
Status
Active (not recruiting)
Treatment
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
Arms:
Scaffold and adipose-derived stromal cell enriched fat grafts
Size
5
Primary endpoint
Volume assessment
Baseline, three months, Six months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Triple blinded, randomized, paired study on healthy participants', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}
Updated at
2022-11-28

1 organization

1 product

2 indications

Organization
Stemform
Product
Scaffold and adipose-derived stromal cell enriched fat grafts
Indication
Augmentation
Indication
Reconstruction