Clinical trial NCT02603744: Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)
Official 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Premature Ovarian Failure
Keywords: Premature ovarian failure adipose derived stromal cells intraovarian injection
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2015-11-13
Enrollment: 9
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: Inclusion Criteria:

* female
* Age : 20-39
* FSH\>20

Exclusion Criteria:

* liposuction contraindication
* thyroid dysfunction
* immune system disease
* past history of cancer , chemotherapy , radiotherapy
* HIV+, hepatitis B, C
* Severe endometriosis

Primary outcomes:
measure: ovary mass
timeFrame: up to 12months
measure: ovary abcess
timeFrame: Up to 12 months
Secondary outcomes:
measure: Follicle Stimulating Hormone (FSH) serum level
timeFrame: Up to 12months
measure: Anti-Mullerian Hormone (AMH) serum level
timeFrame: Up to 12months
measure: Number of antral follicle
timeFrame: Up to 12months
measure: Antral follicle volume
timeFrame: Up to 12months
measure: Menstruation recurrence rate
timeFrame: Up to 12 months
measure: Pregnancy rate
timeFrame: Up to 12months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
name: Tahereh Madani, MD
role: STUDY_DIRECTOR
affiliation: Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
name: Mehri Mashayekhi, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Medicin, Royan Institute
name: Elham sadat Mirzadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mashayekhi M, Mirzadeh E, Chekini Z, Ahmadi F, Eftekhari-Yazdi P, Vesali S, Madani T, Aghdami N. Evaluation of safety, feasibility and efficacy of intra-ovarian transplantation of autologous adipose derived mesenchymal stromal cells in idiopathic premature ovarian failure patients: non-randomized clinical trial, phase I, first in human. J Ovarian Res. 2021 Jan 6;14(1):5. doi: 10.1186/s13048-020-00743-3.