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.

2ABC Therapy

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).

2018-01-31

2020-01-18

2020-01-18

Completed

Early phase I

100

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 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 * Etiology * traumatic * burns * surgical Cutis laxa eligibility conditions: * Sun discoloration * Pigmentation changes * 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 Exclusion Criteria: 1. Active cancer (diagnosed during past 5 years), excluding cured nonmelanoma 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, hepatitis B virus (HBV) or hepatitis C virus (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. Fitzpatrick 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-hepatitis B core antigen (Anti-HBc); * Hepatitis C Virus Infection, Anti-HCV; * Syphilis specific tests

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-02-01