Autologous Bone Marrow Transplantation for Premature Ovarian Insufficiency (BMT-POI)
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|ClinicalTrials.gov Identifier: NCT02779374|
Recruitment Status : Unknown
Verified October 2016 by Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University.
Recruitment status was: Active, not recruiting
First Posted : May 20, 2016
Last Update Posted : October 21, 2016
Currently, There is no treatment for Premature ovarian insufficiency (POI). Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are able to regenerate the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.
Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency.
Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.
|Condition or disease||Intervention/treatment||Phase|
|Premature Ovarian Failure||Other: Autologous bone marrow transplantation||Not Applicable|
Premature ovarian insufficiency (POI) has no curative treatment until now. It was noticed that some cases of POI to recover spontaneously. Furthermore, the concept of fixed prenatal pool of oogonia has been challenged and postnatal neo-oogenesis is currently proved.
Very small embryonic-like stem cells (VSELs) are found in the ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal insufficiency. Data from animal studies showed that stimulation of these stem cells result in regeneration of the affected ovary. Stimulation was achieved by injection of mesenchymal stem cells that is supposed to secrete trophic factors.
Numerous studies in mice have proved the efficacy of bone marrow transplantation (BMT) in resuming the ovarian function after chemotherapy-induced ovarian insufficiency. These studies have been followed by researches on human being. Human studies included the use of stem cells from different sites including BM, adipose tissue, and umbilical cord.
Allogeneic BMT raised the moral conflict about the origin of the newly developed oocytes. Although studies proved that these newly developed oocytes to be genetically traced to the recipient; some other studies showed that the newly developed oocytes originate from the donor BM. Several small studies examined the use of autologous BMT both in animal and in human. The results of these studies were promising. Use of autologous BMT also avoids the need for chemotherapy for conditioning and other related complications associated with allogeneic BMT. Human studies mostly used the ovarian injection of the BM. Intravenous injection is simpler and less invasive than ovarian injection as the later involves the use of laparoscopy. However, intravenous injection has not tested until now.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Bone Marrow Transplantation for Treatment of Premature Ovarian Insufficiency|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: Autologous bone marrow transplantation
autologous bone marrow will be given by intravenous infusion. the intervention will be preceded by a period of 6 months of follow up the a period of 12 months follow up
Other: Autologous bone marrow transplantation
Bone marrow aspiration of 10 ml/kg is done from the posterior iliac crest. The sample is put in sterile container with appropriate amount of heparin then filtered to remove bone spicules, fat, and cellular debris. The filtered sample is injected unprocessed in a peripheral vein. The process is done once.
- menses [ Time Frame: 6 months ]return of menses in a woman with previous ameneorrhea of at least 4 months before recruitment and during the 6 months of the pretest period
- Pregnancy [ Time Frame: 12 months ]Occurrence of pregnancy during the period of 12 months of the post-test follow up
- FSH [ Time Frame: 12 months ]normalization of FSH (below 10 IU/L)
- Antimullarian hormone (AMH) [ Time Frame: 12 months ]normalization of AMH (above 0.9 ng/mL)
- follicular activity [ Time Frame: 12 months ]Growth of ovarian follicles to a size at least 18 mm in diameter
- Endometrial thickness [ Time Frame: 12 months ]Increase in endometrial thickness at least 8 mm.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779374
|South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department|
|Principal Investigator:||Mohammad AM Ahmed, MD||Egypt, Qena, South Valley University, faculty of Medicine|