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Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

Primary Purpose

Premature Ovarian Failure

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Failure focused on measuring Premature ovarian failure adipose derived stromal cells intraovarian injection

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

5 million MSC

10 million MSC

15 million MSC

Arm Description

The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.

The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.

The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Follicle Stimulating Hormone (FSH) serum level
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
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
Number of antral follicle
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
Antral follicle volume
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
Menstruation recurrence rate
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
Pregnancy rate
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

Full Information

First Posted
November 7, 2015
Last Updated
April 26, 2017
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02603744
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
Premature ovarian failure adipose derived stromal cells intraovarian injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 million MSC
Arm Type
Experimental
Arm Description
The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.
Arm Title
10 million MSC
Arm Type
Experimental
Arm Description
The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.
Arm Title
15 million MSC
Arm Type
Experimental
Arm Description
The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.
Intervention Type
Biological
Intervention Name(s)
Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Other Intervention Name(s)
stem cell transplantation
Intervention Description
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Primary Outcome Measure Information:
Title
ovary mass
Description
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.
Time Frame
up to 12months
Title
ovary abcess
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Follicle Stimulating Hormone (FSH) serum level
Description
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
Time Frame
Up to 12months
Title
Anti-Mullerian Hormone (AMH) serum level
Description
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
Time Frame
Up to 12months
Title
Number of antral follicle
Description
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
Time Frame
Up to 12months
Title
Antral follicle volume
Description
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
Time Frame
Up to 12months
Title
Menstruation recurrence rate
Description
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
Time Frame
Up to 12 months
Title
Pregnancy rate
Description
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
Time Frame
Up to 12months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD, PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
Leara91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tahereh Madani, MD
Organizational Affiliation
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehri Mashayekhi, MD
Organizational Affiliation
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elham sadat Mirzadeh, MD
Organizational Affiliation
Department of Regenerative Medicin, Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
Leara91@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33407794
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.
Results Reference
derived
Links:
URL
http://RoyanInstitute.org
Description
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Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

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