laser therapy
Procedurenon-ablative fractional laser therapy of skin
NCT Number: NCT03887208
The aim of this study is to compare clinical outcomes of patients with large scars or Cutis laxa treated with injections of autologous stromal vascular fraction cells (SVF) and adipose-derived mesenchymal stem cells (ADSC).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Laboratory for Cell Research and Application, Medical University of Warsaw, Warsaw, Poland
Patients suffering from cutis laxa senilis and scars (atrophic, hypertrophic, developed due to surgery, trauma, diseases such as acne vulgaris, post-burn scars) will be treated with product containing - human autologous stromal vascular fraction (SVF) cells and human autologous adipose-derived mesenchymal stem cells (ADSC)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Scar eligibility conditions:
Cutis laxa eligibility conditions:
Exclusion criteria
non-ablative fractional laser therapy of skin
Subcutaneous injection of autologous ADSC
Subcutaneous Normal saline injection
Time frame: 0-27 weeks
Evaluation of the effectiveness of the method of application of stem cells in the described indications by evaluating the time after which there will be an improvement of 50% in the point evaluation scale of the quality of life of the patient in relation to the baseline values.
Scale 1: Impact of skin problems on the quality of life. The aim is to assess to what extent skin ailments have affected the patient's life in the last 2 weeks.
A five-level scale of evaluation (from 'very strong' to 'not applicable') .The "very strong" value means the worst result, while the "not applicable" value is the best result.
Time frame: 0-27 weeks
Scale 2: A seven-level grading scale (from "0" to "6").The value "0" means the best result, while "6" is the worst result.
Time frame: 0-27 weeks
Scale 3: Six-point scale (from '1' to '6'). The value "1" means the best result, while "6" is the worst result.
Time frame: 0-27 weeks
Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.
Time frame: 0-27 weeks
Changes in skin surface morphology assessed by digital imaging.
Time frame: 0-27 weeks
Evaluation of safety of the method of cells' application assessed by adverse events
Medical University of Warsaw
Other
Evaluation the Safety and Efficacy of the Treatment of Scars and Cutis Laxa Syndrome With the Use of Autologous (Fresh and Stored) Stem Cells Isolated From Adipose Tissue.
Acronym: 2ABC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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