Inicio
Entrar
Ayuda
Buscar en este sitio:
Ensayos Registrados
Por tipo de intervención
Por estado de reclutamiento
Por promotor
Por fecha de registro
Búsqueda avanzada de ensayos
Proceso de Registro
Para registrar un ensayo
Formulario del Promotor
Formulario de ensayos del RPCEC
Para actualizar un ensayo registrado
Para reportar los resultados de un ensayo registrado
Inicio
|
Stem cell assisted centrifugal fat transfer
View current
Revisiones
List all revisions
Ver
Compare to current
26 Marzo 2021 - 10:34am
por Gladys
26 Marzo 2021 - 1:39pm
por lazara
No hay cambios visibles
Revisión de 26 Marzo 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
Primary sponsor:
"Hermanos Ameijeiras" Surgical Clinical Hospital
Secondary sponsor:
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
País:
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
País:
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
País:
Cuba
Zip Code:
10400
Telephone:
+53-78761233
Email :
cplastica@hha.sld.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
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
Correo electrónico:
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
Date of available results:
01/12/2022
Date of first publication:
01/03/2023
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:
Click here
Acerca del RPCEC
Estructura y Gobernanza
Política
Publicaciones
Reconocimientos
Comunicaciones
Noticias
Recursos útiles
Fundamentos del registro
Bibliografías en ensayos clínicos
Regulaciones cubanas
Otros registros
Plataforma Internacional de Registros de Ensayos Clínicos