Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells (2ABC)

Medical University of Warsaw

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cicatrix; Keloid; Skin; Cutis Laxa; Scar

Treatments: Biological: Autologous ADSC injection; Procedure: Normal saline injection; Procedure: Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03887208

2016-004110-10 (EudraCT Number)

2ABC Therapy

PL008125 (Other Identifier)

Z4217 (Other Identifier)

267976/13/NCBR/2015 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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)

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Autologous adipose derived stem cells

Experimental group

Description:

Autologous ADSC injection combined with laser therapy of the skin.

Treatment:

Procedure: Laser therapy

Biological: Autologous ADSC injection

Placebo - Normal saline injection

Placebo Comparator group

Description:

Normal sline injection combined with laser therapy of the skin.

Treatment:

Procedure: Laser therapy

Procedure: Normal saline injection