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AzTrials

SkinPhase 1/22ABCNCT03887208

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

A Phase 1/2 study testing Laser therapy, Autologous ADSC injection and Normal saline injection in people with Skin and Scar, run by Medical University of Warsaw at 3 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Skin, Scar, Cutis Laxa
What is being tested?
Laser therapy, Autologous ADSC injection and Normal saline injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesPoland
Study dates
31 Jan 2018to 18 Jan 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

3 sites in 1 country.

Poland3 sites

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

    Warsaw

  • Melitus sp. z o.o.

    Warsaw

  • Timeless Chirurgia Plastyczna Sp. z o. o.

    Warsaw

Other trials in Poland

About this study

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.

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).

Read the 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)

Being tested
Laser therapy, Autologous ADSC injection, Normal saline injection
Keywords
scar treatment, cutis laxa treatment, stromal vascular fraction, adipose-derived mesenchymal stem cells
Medical subject headings
Cicatrix, Cutis Laxa, Keloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser therapyProcedure or surgery

    non-ablative fractional laser therapy of skin

  • Autologous ADSC injectionBiological

    Subcutaneous injection of autologous ADSC

  • Normal saline injectionProcedure or surgery

    Subcutaneous Normal saline injection

Study groups in NCT03887208
Study groupRoleWhat they receive
Autologous adipose derived stem cellsExperimentalAutologous ADSC injection combined with laser therapy of the skin.
Receives: Procedure: Laser therapy; Biological: Autologous ADSC injection
Placebo - Normal saline injectionPlacebo comparatorNormal sline injection combined with laser therapy of the skin.
Receives: Procedure: Laser therapy; Procedure: Normal saline injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0-27 weeks

  2. 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.

    Measured: 0-27 weeks

  3. 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.

    Measured: 0-27 weeks

Secondary outcomes (3)

  1. Changes in volume of the skin (USG)

    Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness.

    Measured: 0-27 weeks

  2. Changes in skin surface morphology (digital imagining)

    Changes in skin surface morphology assessed by digital imaging.

    Measured: 0-27 weeks

  3. Record of adverse events

    Evaluation of safety of the method of cells' application assessed by adverse events

    Measured: 0-27 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start31 Jan 2018
  3. Primary completion18 Jan 2020
  4. Study completion18 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887208
Sponsor's protocol ID
2ABC Therapy
Other IDs
2016-004110-10, 267976/13/NCBR/2015, PL008125, Z4217, 2016
Acronym
2ABC
Status last verified
Jan 2023
First submitted
30 Oct 2018
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Laser therapy, Autologous ADSC injection and Normal saline injection in people with Skin and Scar, run by Medical University of Warsaw at 3 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient's skin condition (time frame: 0-27 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.

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