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 within the project: 'The therapeutic potential of mesenchymal stem cells tested in clinical trials and in vitro - a justification for characterized cells storage'.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2017
INTERVENTION: Product Name: Autologous stromal vascular fraction for scars and cutis laxa syndrome treatment. Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Autologous adipose derived mesenchymal stem cells for scars and cutis laxa syndrome treatment. Pharmaceutical Form: Suspension for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Scar or cutis laxa ; MedDRA version: 20.0 Level: LLT Classification code 10039581 Term: Scar conditions and fibrosis of skin System Organ Class: 100000004863 ; MedDRA version: 20.0 Level: PT Classification code 10011692 Term: Cutis laxa System Organ Class: 10040785 ‐ Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: The purpose of this clinical research is to evaluate the safety and efficacy of therapy using fresh and stored autologous stem cells isolated from adipose tissue injected in patients with scars or cutis laxa syndrome. Primary end point(s): Evaluation of the efficacy of the stem cell application method in the described indications by evaluating the time needed for 50% increase in patient’s quality of life. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Time to first occurence. SECONDARY OUTCOME: Secondary end point(s): 1.A change in the volume of fat layer in place of cells’ application evaluated by changes in the volume of the fat layer at the application site assessed by skin and subcutaneous tissue (USG) thickness and assessment of skin surface morphology by digital imaging according to guidelines in the Investigator's Guide.; 2.A change in the structure of the tissue in place of application: the surface, the circumference, flexibility and thickness of tissue, color and texture in the opinion of the investigator and the patient.; 3.Evaluation of safety of the method of cells’ application assessed by adverse events.; 4.Estimation of the time and cost of the procedure during the study.; Timepoint(s) of evaluation of this end point: Time to first occurence. INCLUSION CRITERIA: 1.Age 18 ‐ 75 years at the time of qualification to the study 2.Signing informed consent form 3.Women / men 4.Scar or cutis laxa a.Scar eligibility conditions: •Area: •Stomach •Limbs •Face •Back •Chest and neck •Onset time: over 6 months •Scars previously untreated •Atrophic and hypertrophic scars •Two scars in close location, each from 2 to 6 cm long and a total surface area of 1 sq. cm to 5 sq. cm or single scar of 8 to 16 cm long and a surface area of 1 to 5 sq.cm or a selected fragment of a scar of a surface area of 1 to 5 sq.cm in case of a scar's surface area bigger than 5 sq.cm. •Etiology •traumatic •burns •surgical b.Cutis laxa eligibility conditions: •Vast sun discoloration. •Pigmentation changes areas. •Solar stains. •Pigment changes also called age spots. •Erythema. •Cracked blood vessels. •Ruby nevus. •Atrophic changes of the skin and subcutaneous tissue •Changes sym
Epistemonikos ID: fddc3c8307a37c897e491e9e56a666626e34fc6a
First added on: Aug 23, 2024