Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)
Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 7, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedApril 27, 2017
April 1, 2017
3 years
November 7, 2015
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ovary mass
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.
up to 12months
ovary abcess
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.
Up to 12 months
Secondary Outcomes (6)
Follicle Stimulating Hormone (FSH) serum level
Up to 12months
Anti-Mullerian Hormone (AMH) serum level
Up to 12months
Number of antral follicle
Up to 12months
Antral follicle volume
Up to 12months
Menstruation recurrence rate
Up to 12 months
- +1 more secondary outcomes
Study Arms (3)
5 million MSC
EXPERIMENTALThe patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.
10 million MSC
EXPERIMENTALThe patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.
15 million MSC
EXPERIMENTALThe patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.
Interventions
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Eligibility Criteria
You may qualify if:
- female
- Age : 20-39
- FSH\>20
You may not qualify if:
- liposuction contraindication
- thyroid dysfunction
- immune system disease
- past history of cancer , chemotherapy , radiotherapy
- HIV+, hepatitis B, C
- Severe endometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Publications (1)
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.
PMID: 33407794DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Head of Royan Institute
- STUDY DIRECTOR
Tahereh Madani, MD
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
- STUDY DIRECTOR
Mehri Mashayekhi, MD
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
- PRINCIPAL INVESTIGATOR
Elham sadat Mirzadeh, MD
Department of Regenerative Medicin, Royan Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2015
First Posted
November 13, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2018
Study Completion
November 1, 2018
Last Updated
April 27, 2017
Record last verified: 2017-04