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Completed

NCT Number: NCT03887208

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Laboratory for Cell Research and Application, Medical University of Warsaw, Warsaw, Poland

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser therapy

Procedure

non-ablative fractional laser therapy of skin

Autologous ADSC injection

Biological

Subcutaneous injection of autologous ADSC

Normal Saline Injection

Procedure

Subcutaneous Normal saline injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Melitus sp. z o.o.
  • Polish Stem Cells Bank S.A.
  • Timeless Chirurgia Plastyczna-Janusz Jaworowski

Registry information

Official study 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.

Acronym: 2ABC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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