Revisions for Stem cell assisted centrifugal fat transfer | Registro Público Cubano de Ensayos Clínicos

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Revision of 26 March 2021 - 1:39pm:

Stem cell assisted centrifugal fat transfer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Efficacy of adipose-derived stem cell-assisted fat transfer by centrifugation in facial rejuvenation. Phase III clinical trial.

Secondary indentifying numbers:

Stem cell assisted centrifugal fat transfer

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Alicia

Midle name:

Maria

Last name:

Tamayo Carbon

Medical Specialty :

Second Degree SpecialistS in Plastic Surgery and Caumatology

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761233

Email address:

cplastica@hha.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

01/10/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Facial aging

Health condition(s) code:

Skin Aging

Aging

Intervention(s):

Study group: Infiltration of local anesthesia with 0.5% lidocaine, in the internal part of the navel. Infiltration of modified Klein anesthetic solution in the peri-umbilical area with a cannula with multiple exit ports. After 10 min, liposuction will be performed using 10 ml syringes connected to 3 mm diameter liposuction cannulas and with a suction pressure that does not exceed half the syringe with the plunger. The movements will be made uniformly. Once sufficient fatty tissue has been obtained for the sample, which can be up to 80 ml, a control of the hemostasis of the donor area and closure of the incision with a 5/0 nylon suture will be performed. The preparation of the fat will continue. The syringe will be disconnected from your liposuction cannula and Lower-Luck plugs will be placed, it will decant for 10 minutes. The infranatant will be removed by gravity. The plunger will be withdrawn from it and will be centrifuged at 3000 rpm for 3 min. Once the process is finished, the syringe will be removed and there will be three layers of product in it: the upper one must be removed by capillarity or absorption with a gauze, the lower one will be removed by removing the Lower-Luck cap and the liquid content will fall by gravity, while the intermediate content is the pure fat itself, which will be enriched with stem cells, which will be obtained by emulsifying the adipose tissue with 30 passages of fracture of the adipocytes that will be transferred between two 10 ml syringes connected with transfer ranging from 2.0 mm to 0.7 mm, the emulsified product will be filtered through a 500-millimeter mesh, the tissue obtained contains a larger population of stem cells obtained by non-enzymatic method. 0.5 ml of the resulting filtered tissue will be added for every 2 ml of centrifuged fat. Finally, it will be applied in the area to be rejuvenated until achieving symmetry on the face and volume in harmony with your physical texture. In unison, the surgical treatment will continue. The processed adipose tissue will be placed in 1cc syringes for its infiltration, with cannulas of 3 mm or less diameter in relation to the thickness of the preparation, with a single distal hole and with a blunt tip, and it will be injected backward into the previously indicated facial regions. through access holes made with local anesthesia and needle. The filling will be placed in micro-reservoirs and different planes until the defect is corrected. Control group: A conventional fat transfer.

Intervention code:

Stem Cells

Rejuvenation

Centrifugation

Intervention keyword:

Lipotransfer, Assisted centrifugation

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Evaluation of the final result: (Good, Fair, Bad). Measurement time: 12 months after the intervention.

Key secondary outcomes:

1. Clinical evolution of furrows and wrinkles (Clinical response to treatment interpreted by doctor and patient, using the Global Aesthetic Improvement Scale (GAIS)] (Exceptional improvement. Total disappearance of wrinkles, Much improved. Marked partial response. Decrease in the number of wrinkles between 50 and 99%, Improved. Slight partial response. Decrease in the number of wrinkles less than 50%, No response. Same as at the beginning of treatment, Progression. Increased number or size of wrinkles )). Measurement time: 12 months after the intervention. 2. Satisfaction status: (Satisfied, Not satisfied). Measurement time: 12 months after the intervention. 3. Complications (Yes, No). Measurement time: 24 and 72 hours, 1 week and, 3, 6 and 12 months after the intervention. 4. Type of complications (Describe complications that appear). Measurement time: 24 and 72 hours, 1 week and, 3, 6 and 12 months after the intervention.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

30 years

Maximum age:

59 years

Inclusion criteria:

1. Patients between the ages of 30 and 59, without distinction of sex. 2. Patients with signs of facial aging. 3. Willingness to participate in the study, with prior written informed consent. 4. Compensated chronic diseases, if you suffer from them.

Exclusion criteria:

1. History of psychiatric disorders or coagulopathies. 2. Patients whose expectations cannot be achieved with the procedure. 3. Pregnant or lactating women. 4. Tendency to keloid. 5. Skin or systemic infection. 6. Patients who are on anticoagulant, antifibrinolytic or non-steroidal anti-inflammatory drugs (NSAIDs) or steroids. 7. History of having made facial lipotransfer or injected other substances as fillers in the face.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

Recruitment for time

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Alicia

Middle Name:

Maria

Last Name:

Tamayo Carbon

Specialty:

Second Degree Specialist in Plastic Surgery and Caumatology

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal Address:

San Lazaro 701 corner Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761233

Email :

cplastica@hha.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Alicia

Middle Name:

Maria

Last Name:

Tamayo Carbon

Specialty:

Second Degree Specialist in Plastic Surgery and Caumatology

Affiliation:

"Hermanos Ameijeiras" Surgical Clinical Hospital

Postal Address:

San Lazaro 701 esq Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761233

Email :

cplastica@hha.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Hermanos Ameijeiras" Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

22/09/2020

Postal address of Ethic Committee :

San Lazaro Street, between Belascoain and Marquez Gonzalez. Havana. Cuba

Telephone:

+53-78761626

Email:

invest1@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

46

Study completion date:

30/09/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000362

Date of Registration in Primary Registry:

26/03/2021

Record Verification Date:

2021/03/26

Next update date:

2022/03/26

Link to the spanish version:

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26 March 2021 - 10:34am by Gladys		26 March 2021 - 1:39pm by lazara
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Stem cell assisted centrifugal fat transfer

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