Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure (POF)
Objective: Safety and tolerability and early evidence of effectiveness of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure
Design: Study group: Nine POF patient in 3 groups (3 patient in each group), phase I. Blinding: No blinding, randomized single center. Sample size: Nine patients.
Setting and conduct: After trial description and obtaining informed consent, lipoaspiration will be performed and mesenchymal stem cells will be isolated and cultivated in clean room. Intra ovarian injection of 5 million ADSC will performed in first group via a transvaginal sonographical guided intra ovarian injection. After establishing the safety of this step, the injection of 10 million of ADSC will performed for second group and then the 3rd group will be transplanted with 15 million. All the patients will be followed within one year according to the protocol. At the end of one year after last patient transplantation the data with gathered and analyze.
Inclusion/exclusion criteria: All women under 39 years old and normal karyotype who have not the exclusion criteria with premature ovarian failure
Interventions: Intra ovarian injection of autologous ADSC
Primary outcome: Safety, Secondary outcome: Early evidence of effectiveness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510271031N18
Registration date:2015-12-29, 1394/10/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure (POF)
Public title
Study of autologous adipose derived stromal cell transplantation in women with POF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female; Age: 20-39; FSH>20; One year after POF diagnose; Normal karyotype
Exclusion criteria: Liposuction contraindication; Thyroid dysfunction; Immune system disease; Past history of cancer; Chemotherapy; Radiotherapy; HIV+; Hepatitis B or C; Severe endometriosis
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
9
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT02603744
Registration date
2015-11-07, 1394/08/16
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Royan institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.ACECR.ROYAN.REC.1394.41
Health conditions studied
1
Description of health condition studied
Premature ovarian failure
ICD-10 code
E28.3
ICD-10 code description
Premature menopause NOS
Primary outcomes
1
Description
Number of patient with adverse event
Timepoint
One year after transplantation
Method of measurement
Adverse event report form
Secondary outcomes
1
Description
Number of antral follicle
Timepoint
Base line,1,2,4,8 and 12 weeks, 6 month and 1 year after transplantation
Method of measurement
Sonography
2
Description
AMH serum level
Timepoint
Base line and 1 year after transplantation
Method of measurement
Laboratory test
3
Description
FSH serum level
Timepoint
Base line,1,2,4,8 and 12 weeks, 6 month and 1 year after transplantation
Method of measurement
Laboratory test
4
Description
Antral follicle volume
Timepoint
Base line,1,2,4,8 and 12 weeks, 6 month and 1 year after transplantation
Method of measurement
Sonography
5
Description
Menstruation recurrence rate
Timepoint
Base line,1,2,4,8 and 12 weeks, 6 month and 1 year after transplantation
Method of measurement
Questionary
6
Description
Pregnancy rate
Timepoint
One year after transplantation
Method of measurement
Beta-hCG serum level
Intervention groups
1
Description
Intervention: Intra ovarian injection of 1 cc of cell suspension of autologous ADSC in autologous serum
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Royan's Infertility Clinic
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Elham Mirzade
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
dr.mirzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nasser Aghdami
Position
M.D,Ph.D
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
+98 21 2251 6465
Email
hoda62_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)