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

Scar Clinical Trial

— 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.

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
• 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
• 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

Related Conditions & MeSH terms

• Cicatrix
• Cutis Laxa
• Keloid
• Scar
• Skin

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