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Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells (2ABC)

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ClinicalTrials.gov Identifier: NCT03887208
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
Timeless Chirurgia Plastyczna-Janusz Jaworowski
Melitus sp. z o.o.
Polish Stem Cells Bank S.A.
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Skin Scar Cutis Laxa Keloid Cicatrix Procedure: Laser therapy Biological: Autologous ADSC injection Procedure: Normal saline injection Phase 1 Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Autologous adipose derived stem cells
Autologous ADSC injection combined with laser therapy of the skin.
Procedure: Laser therapy
non-ablative fractional laser therapy of skin

Biological: Autologous ADSC injection
Subcutaneous injection of autologous ADSC

Placebo Comparator: Placebo - Normal saline injection
Normal sline injection combined with laser therapy of the skin.
Procedure: Laser therapy
non-ablative fractional laser therapy of skin

Procedure: Normal saline injection
Subcutaneous Normal saline injection




Primary Outcome Measures :
  1. Change in patient's skin condition [ Time Frame: 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.


  2. Evaluation of skin problems. Assessment of skin related complaints since the last visit. [ Time Frame: 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.

  3. The assessment of the scar by the patient. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Changes in volume of the skin (USG) [ Time Frame: 0-27 weeks ]
    Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.

  2. Changes in skin surface morphology (digital imagining) [ Time Frame: 0-27 weeks ]
    Changes in skin surface morphology assessed by digital imaging.

  3. Record of adverse events [ Time Frame: 0-27 weeks ]
    Evaluation of safety of the method of cells' application assessed by adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    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
  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

Exclusion Criteria:

  1. Active cancer (diagnosed during past 5 years), excluding cured nonmelanoma 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, hepatitis B virus (HBV) or hepatitis C virus (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. Fitzpatrick 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-hepatitis B core antigen (Anti-HBc);
    • Hepatitis C Virus Infection, Anti-HCV;
    • Syphilis specific tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887208


Contacts
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Contact: Malgorzata Lewandowska-Szumiel, Professor +48221166115 malgorzata.lewandowska-szumiel@wum.edu.pl

Locations
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Poland
Laboratory for Cell Research and Application, Medical University of Warsaw Active, not recruiting
Warsaw, Poland
Melitus sp. z o.o. Recruiting
Warsaw, Poland
Principal Investigator: Maria Noszczyk-Kostrzewa, PhD         
Timeless Chirurgia Plastyczna Sp. z o. o. Recruiting
Warsaw, Poland
Principal Investigator: Janusz R Jaworowski, PhD         
Sponsors and Collaborators
Medical University of Warsaw
Timeless Chirurgia Plastyczna-Janusz Jaworowski
Melitus sp. z o.o.
Polish Stem Cells Bank S.A.
Investigators
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Study Chair: Maria Noszczyk-Kostrzewa, PhD Melitus Ltd
Principal Investigator: Janusz R Jaworowski, PhD Timeless Ltd

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03887208     History of Changes
Other Study ID Numbers: 2ABC Therapy
2016-004110-10 ( EudraCT Number )
267976/13/NCBR/2015 ( Other Grant/Funding Number: The National Center for Research and Development, Poland )
PL008125 ( Other Identifier: EU tissue establishment code )
Z4217 ( Other Identifier: ISBT128 (Facility Identification Number) )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medical University of Warsaw:
scar treatment
cutis laxa treatment
stromal vascular fraction
adipose-derived mesenchymal stem cells
Additional relevant MeSH terms:
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Cutis Laxa
Cicatrix
Fibrosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases