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

Medical University of Warsaw100 enrolled

Overview

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).

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Skin Scar Cutis Laxa Keloid Cicatrix

Interventions

Laser therapyPROCEDURE

non-ablative fractional laser therapy of skin

Autologous ADSC injectionBIOLOGICAL

Subcutaneous injection of autologous ADSC

Normal saline injectionPROCEDURE

Subcutaneous Normal saline injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Laboratory for Cell Research and Application, Medical University of Warsaw

Warsaw, Poland

Melitus sp. z o.o.

Warsaw, Poland

Timeless Chirurgia Plastyczna Sp. z o. o.

Warsaw, Poland

Outcomes

Primary Outcomes

Change in patient's skin condition

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

Evaluation of skin problems. Assessment of skin related complaints since the last visit.

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

The assessment of the scar by the patient.

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

Secondary Outcomes

Changes in volume of the skin (USG)

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 (digital imagining)

Changes in skin surface morphology assessed by digital imaging.

Time frame: 0-27 weeks

Record of adverse events

Evaluation of safety of the method of cells' application assessed by adverse events

Time frame: 0-27 weeks

Data from ClinicalTrials.gov

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