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

Premature Ovarian Failure Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02603744
• Other study ID #: Rep-Bio-Royan-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 7, 2015
• Last updated: April 26, 2017
• Start date: June 2015
• Est. completion date: November 2018

Study information

• Verified date: April 2017
• Source: Royan Institute
• Contact: Nasser Aghdami, MD, PhD
• Phone: (+98)23562000
• Email: nasser.aghdami[@]royaninstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• Intraovarian injection of Adipose derived Stromal cells (ADSCs)
Intra-ovarian injection of Adipose derived mesenchymal stem cells.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Up to 12months
Secondary	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	Up to 12months
Secondary	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	Up to 12months
Secondary	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	Up to 12months
Secondary	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	Up to 12 months
Secondary	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	Up to 12months

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