NCT03887208

Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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)

Conditions

• Skin
• Scar
• Cutis Laxa
• Keloid
• Cicatrix

Interventions

Type	Name	Description
PROCEDURE	Laser therapy	non-ablative fractional laser therapy of skin
BIOLOGICAL	Autologous ADSC injection	Subcutaneous injection of autologous ADSC
PROCEDURE	Normal saline injection	Subcutaneous Normal saline injection

Timeline

• Start date: 2018-01-31
• Primary completion: 2020-01-18
• Completion: 2020-01-18
• First posted: 2019-03-22
• Last updated: 2023-02-01

Locations

3 sites across 1 country: Poland