Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells
- Conditions
- SkinCutis LaxaCicatrixScarKeloid
- Interventions
- Procedure: Laser therapyBiological: Autologous ADSC injectionProcedure: Normal saline injection
- Registration Number
- NCT03887208
- Lead Sponsor
- Medical University of Warsaw
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
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.
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Patient's health which allows anesthesia for liposuction.
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Ready for follow-up visits
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Active cancer (diagnosed during past 5 years), excluding cured nonmelanoma skin cancer or other non-invasive or in situ cancer (eg. cervical cancer)
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Active chronic infection
-
Chronic use of NSAIDs
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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.
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Skin infections.
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Allergies to medications used during liposuction (eg. Lidocaine and derivatives).
-
Status post radiotherapy or chemotherapy
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Any other disease or condition that may change the evaluation of skin condition (eg. autoimmune disease of the connective tissue)
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Taking the corticosteroid drugs or cytotoxic medications during the past 30 days
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Allergy to materials of animal origin
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Diagnosis of diabetes Type I
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Diagnosis of AIDS, hepatitis B virus (HBV) or hepatitis C virus (HCV) (positive laboratory test result)
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Hirsutism or a tattoo at the treatment site
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Insufficient fat tissue for fat donation
-
Scar after removal of cancer.
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The patient does not qualify to participate in this study in the opinion of the investigator
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous adipose derived stem cells Autologous ADSC injection Autologous ADSC injection combined with laser therapy of the skin. Placebo - Normal saline injection Normal saline injection Normal sline injection combined with laser therapy of the skin. Autologous adipose derived stem cells Laser therapy Autologous ADSC injection combined with laser therapy of the skin. Placebo - Normal saline injection Laser therapy Normal sline injection combined with laser therapy of the skin.
- Primary Outcome Measures
Name Time Method The assessment of the scar by the patient. 0-27 weeks Scale 3: Six-point scale (from '1' to '6'). The value "1" means the best result, while "6" is the worst result.
Evaluation of skin problems. Assessment of skin related complaints since the last visit. 0-27 weeks Scale 2: A seven-level grading scale (from "0" to "6").The value "0" means the best result, while "6" is the worst result.
Change in patient's skin condition 0-27 weeks 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.
- Secondary Outcome Measures
Name Time Method Changes in skin surface morphology (digital imagining) 0-27 weeks Changes in skin surface morphology assessed by digital imaging.
Changes in volume of the skin (USG) 0-27 weeks Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.
Record of adverse events 0-27 weeks Evaluation of safety of the method of cells' application assessed by adverse events
Trial Locations
- 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