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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells. |
|
| 10 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells. |
|
| 15 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraovarian injection of Adipose derived Stromal cells (ADSCs) | Biological | Intra-ovarian injection of Adipose derived mesenchymal stem cells. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser Aghdami, MD, PhD | Contact | (+98)23562000 | 516 | nasser.aghdami@royaninstitute.org |
| Leila Arab, MD | Contact | (+98)23562000 | 414 | Leara91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Tahereh Madani, MD | Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33407794 | Derived | Mashayekhi M, Mirzadeh E, Chekini Z, Ahmadi F, Eftekhari-Yazdi P, Vesali S, Madani T, Aghdami N. Evaluation of safety, feasibility and efficacy of intra-ovarian transplantation of autologous adipose derived mesenchymal stromal cells in idiopathic premature ovarian failure patients: non-randomized clinical trial, phase I, first in human. J Ovarian Res. 2021 Jan 6;14(1):5. doi: 10.1186/s13048-020-00743-3. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| 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 |
| Mehri Mashayekhi, MD | Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. | Study Director |
| Elham sadat Mirzadeh, MD | Department of Regenerative Medicin, Royan Institute | Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |