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

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ClinicalTrials.gov Identifier: NCT02603744
Recruitment Status : Unknown
Verified April 2017 by Royan Institute.
Recruitment status was:  Recruiting
First Posted : November 13, 2015
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs) Phase 1 Phase 2

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5 million MSC
The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.
Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Other Name: stem cell transplantation

Experimental: 10 million MSC
The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.
Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Other Name: stem cell transplantation

Experimental: 15 million MSC
The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.
Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Other Name: stem cell transplantation




Primary Outcome Measures :
  1. ovary mass [ Time Frame: 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.

  2. ovary abcess [ Time Frame: 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.


Secondary Outcome Measures :
  1. Follicle Stimulating Hormone (FSH) serum level [ Time Frame: 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

  2. Anti-Mullerian Hormone (AMH) serum level [ Time Frame: 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

  3. Number of antral follicle [ Time Frame: 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

  4. Antral follicle volume [ Time Frame: 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

  5. Menstruation recurrence rate [ Time Frame: 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

  6. Pregnancy rate [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603744


Contacts
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Contact: Nasser Aghdami, MD, PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414 Leara91@gmail.com

Locations
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Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)23562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)23562000 ext 414    Leara91@gmail.com   
Sponsors and Collaborators
Royan Institute
Investigators
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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

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02603744     History of Changes
Other Study ID Numbers: Rep-Bio-Royan-001
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Royan Institute:
Premature ovarian failure adipose derived stromal cells intraovarian injection

Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases