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Premature Ovarian FailureBMT-POINCT02779374

Autologous Bone Marrow Transplantation for Premature Ovarian Insufficiency

A study testing Autologous bone marrow transplantation in people with Premature Ovarian Failure, run by South Valley University at 1 site in Egypt.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 40 years, women only
Conditions the study is for
Premature Ovarian Failure
What is being tested?
Autologous bone marrow transplantation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
Jul 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 40 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Women with POI: For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).

Who cannot join

  • Abnormal karyotype
  • Previous pelvic or abdominal radiotherapy
  • Previous surgical management of ovarian pathology
  • Chronic disease: renal, liver, cardiac, malignancy

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department

    Qina, Qena Governorate

Other trials in Egypt

About this study

Official title: Autologous Bone Marrow Transplantation for Treatment of Premature Ovarian Insufficiency

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.

Read the detailed description

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.

Being tested
Autologous bone marrow transplantation
Keywords
ovarian insufficiency Bone Marrow
Medical subject headings
Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous bone marrow transplantationOther

    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.

Study groups in NCT02779374
Study groupRoleWhat they receive
Autologous bone marrow transplantationExperimentalautologous 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
Receives: Other: Autologous bone marrow transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. menses

    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

    Measured: 6 months

Secondary outcomes (5)

  1. Pregnancy

    Occurrence of pregnancy during the period of 12 months of the post-test follow up

    Measured: 12 months

  2. FSH

    normalization of FSH (below 10 IU/L)

    Measured: 12 months

  3. Antimullarian hormone (AMH)

    normalization of AMH (above 0.9 ng/mL)

    Measured: 12 months

  4. follicular activity

    Growth of ovarian follicles to a size at least 18 mm in diameter

    Measured: 12 months

  5. Endometrial thickness

    Increase in endometrial thickness at least 8 mm.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779374
Sponsor's protocol ID
OBGYN002
Acronym
BMT-POI
Status last verified
Sep 2021
First submitted
18 May 2016
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Santiquet N, Vallieres L, Pothier F, Sirard MA, Robert C, Richard F. Transplanted bone marrow cells do not provide new oocytes but rescue fertility in female mice following treatment with chemotherapeutic agents. Cell Reprogram. 2012 Apr;14(2):123-9. doi: 10.1089/cell.2011.0066.

    PubMed 22471934

  • Dan S, Haibo L, Hong L. Pathogenesis and stem cell therapy for premature ovarian failure. OA Stem Cells 2014 Feb 10;2(1):4.

  • Hershlag A, Schuster MW. Return of fertility after autologous stem cell transplantation. Fertil Steril. 2002 Feb;77(2):419-21. doi: 10.1016/s0015-0282(01)02987-9.

    PubMed 11821109

  • Vassena R, Eguizabal C, Heindryckx B, Sermon K, Simon C, van Pelt AM, Veiga A, Zambelli F; ESHRE special interest group Stem Cells. Stem cells in reproductive medicine: ready for the patient? Hum Reprod. 2015 Sep;30(9):2014-21. doi: 10.1093/humrep/dev181. Epub 2015 Jul 22.

    PubMed 26202914

  • Edessy M, Hosni HN, Shady Y, Waf Y, Bakr S, Kamel M. Autologous stem cells therapy, the first baby of idiopathic premature ovarian failure. Acta Medica International. 2016;3(1):19-23.

  • Lee HJ, Selesniemi K, Niikura Y, Niikura T, Klein R, Dombkowski DM, Tilly JL. Bone marrow transplantation generates immature oocytes and rescues long-term fertility in a preclinical mouse model of chemotherapy-induced premature ovarian failure. J Clin Oncol. 2007 Aug 1;25(22):3198-204. doi: 10.1200/JCO.2006.10.3028.

    PubMed 17664466

  • Hanna CB, Hennebold JD. Ovarian germline stem cells: an unlimited source of oocytes? Fertil Steril. 2014 Jan;101(1):20-30. doi: 10.1016/j.fertnstert.2013.11.009.

    PubMed 24382341

  • Bhartiya D, Anand S, Parte S. VSELs may obviate cryobanking of gonadal tissue in cancer patients for fertility preservation. J Ovarian Res. 2015 Nov 17;8:75. doi: 10.1186/s13048-015-0199-2.

    PubMed 26576728

  • Ghadami M, El-Demerdash E, Zhang D, Salama SA, Binhazim AA, Archibong AE, Chen X, Ballard BR, Sairam MR, Al-Hendy A. Bone marrow transplantation restores follicular maturation and steroid hormones production in a mouse model for primary ovarian failure. PLoS One. 2012;7(3):e32462. doi: 10.1371/journal.pone.0032462. Epub 2012 Mar 7.

    PubMed 22412875

Questions about this trial

What is this clinical trial studying?

A study testing Autologous bone marrow transplantation in people with Premature Ovarian Failure, run by South Valley University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

menses (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779374, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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