Trial | NCT03887208  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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 Started
Jan 31
2018
Primary Completion
Jan 31
2019
Study Completion
Jan 31
2019
Last Update
Jan 28
2020

Procedure Laser therapy

non-ablative fractional laser therapy of skin

Biological Autologous ADSC injection

Subcutaneous injection of autologous ADSC

Procedure Normal saline injection

Subcutaneous Normal saline injection

Autologous adipose derived stem cells Experimental

Autologous ADSC injection combined with laser therapy of the skin.

Placebo - Normal saline injection Placebo Comparator

Normal sline injection combined with laser therapy of the skin.

Criteria 

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
No Results Posted