EUCTR2016-004110-10-PL
Active, Not Recruiting
Phase 1
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 within the project: 'The therapeutic potential of mesenchymal stem cells tested in clinical trials and in vitro - a justification for characterized cells storage'.
Medical University of Warsaw0 sites100 target enrollmentMay 12, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical University of Warsaw
- Enrollment
- 100
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •a.Scar eligibility conditions:
- •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 of 8 to 16 cm long and a surface area of 1 to 5 sq.cm or a selected fragment of a scar of a surface area of 1 to 5 sq.cm in case of a scar's surface area bigger than 5 sq.cm.
Exclusion Criteria
- •1\.Active cancer (diagnosed during past 5 years), excluding cured non\-melanoma 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
Outcomes
Primary Outcomes
Not specified
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