Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells
2ABC
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.
5 other identifiers
interventional
100
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2018
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2020
CompletedFebruary 1, 2023
January 1, 2023
2 years
October 30, 2018
January 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Changes in volume of the skin (USG)
0-27 weeks
Changes in skin surface morphology (digital imagining)
0-27 weeks
Record of adverse events
0-27 weeks
Study Arms (2)
Autologous adipose derived stem cells
EXPERIMENTALAutologous ADSC injection combined with laser therapy of the skin.
Placebo - Normal saline injection
PLACEBO COMPARATORNormal sline injection combined with laser therapy of the skin.
Interventions
non-ablative fractional laser therapy of skin
Subcutaneous injection of autologous ADSC
Subcutaneous Normal saline injection
Eligibility Criteria
You may qualify if:
- 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
- +17 more criteria
You may not qualify if:
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Warsawlead
- Timeless Chirurgia Plastyczna-Janusz Jaworowskicollaborator
- Melitus sp. z o.o.collaborator
- Polish Stem Cells Bank S.A.collaborator
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Noszczyk-Kostrzewa, PhD
Melitus Ltd
- PRINCIPAL INVESTIGATOR
Janusz R Jaworowski, PhD
Timeless Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
March 22, 2019
Study Start
January 31, 2018
Primary Completion
January 18, 2020
Study Completion
January 18, 2020
Last Updated
February 1, 2023
Record last verified: 2023-01