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

M

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

  • Age 18 - 75 years at the time of qualification to the study
  • Signing informed consent form
  • Women / men

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
  • Without previous aesthetic treatment in this area, previous standard care.
  • Patient's health which allows anesthesia for liposuction.
  • Ready for follow-up visits

Exclusion criteria

  • Active cancer (diagnosed during past 5 years), excluding cured nonmelanoma skin cancer or other non-invasive or in situ cancer (eg. cervical cancer)
  • Active chronic infection
  • Chronic use of NSAIDs
  • Taking any anticoagulant by the patient during 1 hour prior to surgery (excluding prophylactic heparin before liposuction).
  • Coagulation disorders in medical history and actual test results out of normal ranges.
  • Skin infections.
  • Allergies to medications used during liposuction (eg. Lidocaine and derivatives).
  • Status post radiotherapy or chemotherapy
  • Any other disease or condition that may change the evaluation of skin condition (eg. autoimmune disease of the connective tissue)
  • Taking the corticosteroid drugs or cytotoxic medications during the past 30 days
  • Allergy to materials of animal origin
  • Diagnosis of diabetes Type I
  • Diagnosis of AIDS, hepatitis B virus (HBV) or hepatitis C virus (HCV) (positive laboratory test result)
  • Hirsutism or a tattoo at the treatment site
  • Insufficient fat tissue for fat donation
  • Scar after removal of cancer.
  • The patient does not qualify to participate in this study in the opinion of the investigator
  • Pregnancy, breast feeding.
  • Photoallergy or using the drugs causing photoallergy.
  • Active herpes
  • Idiopathic keloids
  • Esthetic or medicinal treatments done previously at the treatment site
  • The use of derivatives of vitamin A during 6 months before the treatment
  • Fitzpatrick phototype V and VI
  • Patients with mental disorders or addicted to drugs and/or alcohol.
  • Participation in other clinical study during the past 6 months.

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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