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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-01-18

Brief Summary

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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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Detailed Description

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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)

Conditions

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Skin Scar Cutis Laxa Keloid Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Autologous adipose derived stem cells

Autologous ADSC injection combined with laser therapy of the skin.

Group Type EXPERIMENTAL

Laser therapy

Intervention Type PROCEDURE

non-ablative fractional laser therapy of skin

Autologous ADSC injection

Intervention Type BIOLOGICAL

Subcutaneous injection of autologous ADSC

Placebo - Normal saline injection

Normal sline injection combined with laser therapy of the skin.

Group Type PLACEBO_COMPARATOR

Laser therapy

Intervention Type PROCEDURE

non-ablative fractional laser therapy of skin

Normal saline injection

Intervention Type PROCEDURE

Subcutaneous Normal saline injection

Interventions

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Laser therapy

non-ablative fractional laser therapy of skin

Intervention Type PROCEDURE

Autologous ADSC injection

Subcutaneous injection of autologous ADSC

Intervention Type BIOLOGICAL

Normal saline injection

Subcutaneous Normal saline injection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes