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
Conditions
Interventions
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
Sponsors
Medical University of Warsaw
Eligibility
Sex/Gender
All
Inclusion criteria
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 symmetrically present on both hands 5.Without previous aesthetic treatment in this area, previous standard care. 6.Patient's health which allows anesthesia for liposuction. 7.Ready for follow-up visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1.Active cancer (diagnosed during past 5 years), excluding cured non-melanoma skin cancer or other non-invasive or in situ cancer (eg. cervical cancer) 2.Active chronic infection 3. Chronic use of NSAIDs 4.Taking any anticoagulant by the patient during 1 hour prior to surgery (excluding prophylactic heparin before liposuction). 5.Coagulation disorders in medical history and actual test results out of normal ranges. 6.Skin infections. 7.Allergies to medications used during liposuction (eg. Lidocaine and derivatives). 8.Status post radiotherapy or chemotherapy 9.Any other disease or condition that may change the evaluation of skin condition (eg. autoimmune disease of the connective tissue) 10.Taking the corticosteroid drugs or cytotoxic medications during the past 30 days 11.Allergy to materials of animal origin 12.Diagnosis of diabetes Type I 13.Diagnosis of AIDS, HBV or HCV (positive laboratory test result) 14.Hirsutism or a tattoo at the treatment site 15.Insufficient fat tissue for fat donation 16.Scar after removal of cancer. 17.The patient does not qualify to participate in this study in the opinion of the investigator 18.Pregnancy, breast feeding. 19.Photoallergy or using the drugs causing photoallergy. 20.Active herpes 21.Idiopathic keloids 22.Esthetic or medicinal treatments done previously at the treatment site 23.The use of derivatives of vitamin A during 6 months before the treatment 24.Fitzpatric phototype V and VI 25.Patients with mental disorders or addicted to drugs and/or alcohol. 26.Participation in other clinical study during the past 6 months. 27.Reactive result of serological and viral tests (ie. HIV-1 and 2 (HIV Ag / Ab) •Hepatitis B Virus Infection, – HbsAg and Anti-HBc; •Hepatitis C Virus Infection, Anti-HCV; •Syphilis specific tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Not applicable;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.;Timepoint(s) of evaluation of this end point: Time to first occurence. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Poland
Contacts
Public ContactJanusz Jaworowski PI
Timeless Chirurgia Plastyczna
Outcome results
None listed