Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)
- Conditions
- Premature Ovarian Failure
- Interventions
- Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
- Registration Number
- NCT02603744
- Lead Sponsor
- Royan Institute
- Brief Summary
The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.
- Detailed Description
In this study 9 patients with the diagnosis of premature ovarian failure will participate.
The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs.
Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography.
All the patients will be followed for 12 months after cell injection to evaluate any adverse events .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 9
- female
- Age : 20-39
- FSH>20
- liposuction contraindication
- thyroid dysfunction
- immune system disease
- past history of cancer , chemotherapy , radiotherapy
- HIV+, hepatitis B, C
- Severe endometriosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 million MSC Intraovarian injection of Adipose derived Stromal cells (ADSCs) The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells. 15 million MSC Intraovarian injection of Adipose derived Stromal cells (ADSCs) The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells. 10 million MSC Intraovarian injection of Adipose derived Stromal cells (ADSCs) The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.
- Primary Outcome Measures
Name Time Method ovary abcess Up to 12 months Evaluation the ovary abcess formation up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
ovary mass up to 12months Evaluation the formation of ovary mass by sonography up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
- Secondary Outcome Measures
Name Time Method Pregnancy rate Up to 12months Evaluation the pregnancy rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Follicle Stimulating Hormone (FSH) serum level Up to 12months one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Anti-Mullerian Hormone (AMH) serum level Up to 12months Evaluation the AMH serum level by blood sampling up to one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Antral follicle volume Up to 12months Evaluation the antral follicle volume by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Number of antral follicle Up to 12months Evaluation the number of antral follicle by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Menstruation recurrence rate Up to 12 months Evaluation the menstruation recurrence rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of