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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004110-10 | EudraCT Number | ||
| 267976/13/NCBR/2015 | Other Grant/Funding Number | The National Center for Research and Development, Poland | |
| PL008125 | Other Identifier | EU tissue establishment code | |
| Z4217 | Other Identifier | ISBT128 (Facility Identification Number) |
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| Name | Class |
|---|---|
| Timeless Chirurgia Plastyczna-Janusz Jaworowski | UNKNOWN |
| Melitus sp. z o.o. | UNKNOWN |
| Polish Stem Cells Bank S.A. | UNKNOWN |
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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).
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous adipose derived stem cells | Experimental | Autologous ADSC injection combined with laser therapy of the skin. |
|
| Placebo - Normal saline injection | Placebo Comparator | Normal sline injection combined with laser therapy of the skin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser therapy | Procedure | non-ablative fractional laser therapy of skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in skin surface morphology (digital imagining) |
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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
Etiology
Cutis laxa eligibility conditions:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Maria Noszczyk-Kostrzewa, PhD | Melitus Ltd | Study Chair |
| Janusz R Jaworowski, PhD | Timeless Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Cell Research and Application, Medical University of Warsaw | Warsaw | Poland | ||||
| Melitus sp. z o.o. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D003483 | Cutis Laxa |
| D007627 | Keloid |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D000077324 | Crystalloid Solutions |
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Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
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| Autologous ADSC injection | Biological | Subcutaneous injection of autologous ADSC |
|
| Normal saline injection | Procedure | Subcutaneous Normal saline injection |
|
Changes in skin surface morphology assessed by digital imaging.
| 0-27 weeks |
| Record of adverse events | Evaluation of safety of the method of cells' application assessed by adverse events | 0-27 weeks |
| Warsaw |
| Poland |
| Timeless Chirurgia Plastyczna Sp. z o. o. | Warsaw | Poland |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D003095 | Collagen Diseases |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |