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'.

Phase 1

• Conditions: Scar or cutis laxa; MedDRA version: 20.0Level: LLTClassification code 10039581Term: Scar conditions and fibrosis of skinSystem Organ Class: 100000004863; MedDRA version: 20.0Level: PTClassification code 10011692Term: Cutis laxaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004110-10-PL
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-12
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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:
•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 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.
•Etiology
•traumatic
•burns
•surgical
b.Cutis laxa eligibility conditions:
•Vast sun discoloration.
•Pigmentation changes areas.
•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
5.Without previous aesthetic treatment in this area, previous standard care.
6.Patient's health which allows anesthesia for liposuction.
7.Ready for follow-up visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
11.Allergy to materials of animal origin
12.Diagnosis of diabetes Type I
13.Diagnosis of AIDS, HBV or HCV (positive laboratory test result)
14.Hirsutism or a tattoo at the treatment site
15.Insufficient fat tissue for fat donation
16.Scar after removal of cancer.
17.The patient does not qualify to participate in this study in the opinion of the investigator
18.Pregnancy, breast feeding.
19.Photoallergy or using the drugs causing photoallergy.
20.Active herpes
21.Idiopathic keloids
22.Esthetic or medicinal treatments done previously at the treatment site
23.The use of derivatives of vitamin A during 6 months before the treatment
24.Fitzpatric phototype V and VI
25.Patients with mental disorders or addicted to drugs and/or alcohol.
26.Participation in other clinical study during the past 6 months.
27.Reactive result of serological and viral tests (ie. HIV-1 and 2 (HIV Ag / Ab)
•Hepatitis B Virus Infection, – HbsAg and Anti-HBc;
•Hepatitis C Virus Infection, Anti-HCV;
•Syphilis specific tests

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified