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

Sponsor
Royan Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02603744
Collaborator
(none)
9
Enrollment
1
Location
3
Arms
41
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 .

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • stem cell transplantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royan Institute Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Royan Institute

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Royan Institute
    ClinicalTrials.gov Identifier:
    NCT02603744
    Other Study ID Numbers:
    • Rep-Bio-Royan-001
    First Posted:
    Nov 13, 2015
    Last Update Posted:
    Apr 27, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Royan Institute
    Premature ovarian failure adipose derived stromal cells intraovarian injection
    Additional relevant MeSH terms:
    Premature Birth
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Apr 27, 2017