Clinical trial NCT03887208: Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Skin
Scar
Cutis Laxa
Keloid
Cicatrix
Keywords: scar treatment
cutis laxa treatment
stromal vascular fraction
adipose-derived mesenchymal stem cells
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Timeless Chirurgia Plastyczna-Janusz Jaworowski
name: Melitus sp. z o.o.
name: Polish Stem Cells Bank S.A.
First posted: 2019-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Primary purpose: TREATMENT

Brief 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)

Eligibility 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

   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

Primary outcomes:
measure: Change in patient's skin condition
timeFrame: 0-27 weeks
measure: Evaluation of skin problems. Assessment of skin related complaints since the last visit.
timeFrame: 0-27 weeks
measure: The assessment of the scar by the patient.
timeFrame: 0-27 weeks
Secondary outcomes:
measure: Changes in volume of the skin (USG)
timeFrame: 0-27 weeks
measure: Changes in skin surface morphology (digital imagining)
timeFrame: 0-27 weeks
measure: Record of adverse events
timeFrame: 0-27 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Laboratory for Cell Research and Application, Medical University of Warsaw
city: Warsaw
country: Poland
facility: Melitus sp. z o.o.
city: Warsaw
country: Poland
facility: Timeless Chirurgia Plastyczna Sp. z o. o.
Study officials:
affiliation: Melitus Ltd
name: Maria Noszczyk-Kostrzewa, PhD
role: STUDY_CHAIR
affiliation: Timeless Ltd
name: Janusz R Jaworowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: