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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)

Conditions
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Premature Ovarian Failure

Intervention / Treatment
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* Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 million MSC<br>The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells. | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)<br>* Intra-ovarian injection of Adipose derived mesenchymal stem cells.<br>* Other names: stem cell transplantation;|
| Experimental: 10 million MSC<br>The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells. | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)<br>* Intra-ovarian injection of Adipose derived mesenchymal stem cells.<br>* Other names: stem cell transplantation;|
| Experimental: 15 million MSC<br>The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells. | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)<br>* Intra-ovarian injection of Adipose derived mesenchymal stem cells.<br>* Other names: stem cell transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature ovarian failure adipose derived stromal cells intraovarian injection