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

Primary Purpose

Skin, Scar, Cutis Laxa

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Laser therapy
Autologous ADSC injection
Normal saline injection
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin focused on measuring scar treatment, cutis laxa treatment, stromal vascular fraction, adipose-derived mesenchymal stem cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratory for Cell Research and Application, Medical University of Warsaw
  • Melitus sp. z o.o.
  • Timeless Chirurgia Plastyczna Sp. z o. o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous adipose derived stem cells

Placebo - Normal saline injection

Arm Description

Autologous ADSC injection combined with laser therapy of the skin.

Normal sline injection combined with laser therapy of the skin.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Changes in volume of the skin (USG)
Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.
Changes in skin surface morphology (digital imagining)
Changes in skin surface morphology assessed by digital imaging.
Record of adverse events
Evaluation of safety of the method of cells' application assessed by adverse events

Full Information

First Posted
October 30, 2018
Last Updated
January 31, 2023
Sponsor
Medical University of Warsaw
Collaborators
Timeless Chirurgia Plastyczna-Janusz Jaworowski, Melitus sp. z o.o., Polish Stem Cells Bank S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03887208
Brief Title
Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells
Acronym
2ABC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Timeless Chirurgia Plastyczna-Janusz Jaworowski, Melitus sp. z o.o., Polish Stem Cells Bank S.A.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin, Scar, Cutis Laxa, Keloid, Cicatrix
Keywords
scar treatment, cutis laxa treatment, stromal vascular fraction, adipose-derived mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous adipose derived stem cells
Arm Type
Experimental
Arm Description
Autologous ADSC injection combined with laser therapy of the skin.
Arm Title
Placebo - Normal saline injection
Arm Type
Placebo Comparator
Arm Description
Normal sline injection combined with laser therapy of the skin.
Intervention Type
Procedure
Intervention Name(s)
Laser therapy
Intervention Description
non-ablative fractional laser therapy of skin
Intervention Type
Biological
Intervention Name(s)
Autologous ADSC injection
Intervention Description
Subcutaneous injection of autologous ADSC
Intervention Type
Procedure
Intervention Name(s)
Normal saline injection
Intervention Description
Subcutaneous Normal saline injection
Primary Outcome Measure Information:
Title
Change in patient's skin condition
Description
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.
Time Frame
0-27 weeks
Title
Evaluation of skin problems. Assessment of skin related complaints since the last visit.
Description
Scale 2: A seven-level grading scale (from "0" to "6").The value "0" means the best result, while "6" is the worst result.
Time Frame
0-27 weeks
Title
The assessment of the scar by the patient.
Description
Scale 3: Six-point scale (from '1' to '6'). The value "1" means the best result, while "6" is the worst result.
Time Frame
0-27 weeks
Secondary Outcome Measure Information:
Title
Changes in volume of the skin (USG)
Description
Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.
Time Frame
0-27 weeks
Title
Changes in skin surface morphology (digital imagining)
Description
Changes in skin surface morphology assessed by digital imaging.
Time Frame
0-27 weeks
Title
Record of adverse events
Description
Evaluation of safety of the method of cells' application assessed by adverse events
Time Frame
0-27 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Noszczyk-Kostrzewa, PhD
Organizational Affiliation
Melitus Ltd
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Janusz R Jaworowski, PhD
Organizational Affiliation
Timeless Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for Cell Research and Application, Medical University of Warsaw
City
Warsaw
Country
Poland
Facility Name
Melitus sp. z o.o.
City
Warsaw
Country
Poland
Facility Name
Timeless Chirurgia Plastyczna Sp. z o. o.
City
Warsaw
Country
Poland

12. IPD Sharing Statement

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

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