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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887208
Other study ID # 2ABC Therapy
Secondary ID 2016-004110-1026
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 31, 2018
Est. completion date January 18, 2020

Study information

Verified date January 2023
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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)


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 18, 2020
Est. primary completion date January 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laser therapy
non-ablative fractional laser therapy of skin
Biological:
Autologous ADSC injection
Subcutaneous injection of autologous ADSC
Procedure:
Normal saline injection
Subcutaneous Normal saline injection

Locations

Country Name City State
Poland 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

Sponsors (4)

Lead Sponsor Collaborator
Medical University of Warsaw Melitus sp. z o.o., Polish Stem Cells Bank S.A., Timeless Chirurgia Plastyczna-Janusz Jaworowski

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Changes in volume of the skin (USG) Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness. 0-27 weeks
Secondary Changes in skin surface morphology (digital imagining) Changes in skin surface morphology assessed by digital imaging. 0-27 weeks
Secondary Record of adverse events Evaluation of safety of the method of cells' application assessed by adverse events 0-27 weeks
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