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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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.

Conditions
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Skin, Scar, Cutis Laxa, Keloid, Cicatrix

Intervention / Treatment
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* Procedure: Laser therapy
* Biological: Autologous ADSC injection
* Procedure: Normal saline injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous adipose derived stem cells<br>Autologous ADSC injection combined with laser therapy of the skin. | Procedure: Laser therapy<br>* non-ablative fractional laser therapy of skin<br>Biological: Autologous ADSC injection<br>* Subcutaneous injection of autologous ADSC<br>|
| Placebo Comparator: Placebo - Normal saline injection<br>Normal sline injection combined with laser therapy of the skin. | Procedure: Laser therapy<br>* non-ablative fractional laser therapy of skin<br>Procedure: Normal saline injection<br>* Subcutaneous Normal saline injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's skin condition | 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. | 0-27 weeks | 
| Evaluation of skin problems. Assessment of skin related complaints since the last visit. | Scale 2: A seven-level grading scale (from 0 to 6).The value 0 means the best result, while 6 is the worst result. | 0-27 weeks | 
| The assessment of the scar by the patient. | Scale 3: Six-point scale (from '1' to '6'). The value 1 means the best result, while 6 is the worst result. | 0-27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in volume of the skin (USG) | Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness. | 0-27 weeks | 
| Changes in skin surface morphology (digital imagining) | Changes in skin surface morphology assessed by digital imaging. | 0-27 weeks | 
| Record of adverse events | Evaluation of safety of the method of cells' application assessed by adverse events | 0-27 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar treatment, cutis laxa treatment, stromal vascular fraction, adipose-derived mesenchymal stem cells