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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 7, 2015
First Posted Date  ICMJE November 13, 2015
Last Update Posted Date April 27, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)
Official Title  ICMJE Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Premature Ovarian Failure
Intervention  ICMJE Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
Other Name: stem cell transplantation
Study Arms  ICMJE
  • Experimental: 5 million MSC
    The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.
    Intervention: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
  • Experimental: 10 million MSC
    The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.
    Intervention: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
  • Experimental: 15 million MSC
    The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.
    Intervention: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 10, 2015)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603744
Other Study ID Numbers  ICMJE Rep-Bio-Royan-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP