Premature Ovarian FailurePhase 1NCT04815213
The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans
A Phase 1 study testing expanded autologous bone marrow derived MSC Intravaginally, expanded autologous bone marrow derived MSC Laporoscopic and EV in people with Premature Ovarian Failure, run by University of Jordan at 1 site in Jordan.
Trial summary
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- expanded autologous bone marrow derived MSC Intravaginally, expanded autologous bone marrow derived MSC Laporoscopic and EV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2022to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed and dated informed consent
- Married female, 18-38 years old
- Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 20 IU/L) and/or Primary or secondary amenorrhea at least for 6 months
- Evidence of low ovarian reserve defined as: AMH < _0.3 ng/ML \& FSH >20 IU/L, AFC < 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
- Normal karyotype 46, XX.
- Presence of at least one ovary
Show all 10Show fewer
- Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
- Agree to report any pregnancy to the research staff immediately.
- Cooperative patient
- Negative for infectious panel (HIV, HBV, HCV, and VDRL)
Who cannot join
- Currently breast-feeding
- Has a history of, or evidence of current malignancy
- Major mental health disorder that precludes participation in the study
- Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
- Significant anemia (Hemoglobin <8 g/dL).
Show all 11Show fewer
- Untreated deep venous thrombosis, and/or pulmonary embolus
- Known heart disease (New York Heart Association Class II or higher).
- Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
- Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).
- Clinically active autoimmune condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure
Read the detailed description
MSCs in passage-2 culture will be washed with PBS and detached with trypsin/EDTA (0.25%). After that, the cells will be suspended at a density of 20×106 cells/ 2 ml normal saline and loaded into 3 ml sterile syringes.
The cells should be infused within 2 hours of release. Tests and follow up are to be monthly.
- Conditions
- Premature Ovarian Failure
- Being tested
- expanded autologous bone marrow derived MSC Intravaginally, expanded autologous bone marrow derived MSC Laporoscopic, EV
- 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.
expanded autologous bone marrow derived MSC IntravaginallyBiological
Also called BM-MSc
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
expanded autologous bone marrow derived MSC LaporoscopicBiological
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
EVBiological
Extracellular vesicles injection
| Study group | Role | What they receive |
|---|---|---|
| MSCs Intravaginally | Experimental | Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally Receives: Biological: expanded autologous bone marrow derived MSC Intravaginally |
| MSCs Laparoscopic | Experimental | Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Laparoscopic Receives: Biological: expanded autologous bone marrow derived MSC Laporoscopic |
| EV | Experimental | Extravascular vesicles (EV) injection Receives: Biological: EV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
Measured: 12 months
Secondary outcomes (3)
Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes
Efficacy will be measured comparing hormonal changes (FSH, LH, AMH, estradiol) in patients' blood on monthly intervals
Measured: 12 months
Number of patients with positive ovarian changes
Patients ultrasounds of the ovaries will compare size and follicle numbers
Measured: 12 months
Number of patients with increased endometrial thickness
Ultrasounds of uterus will be compared for endometrial thickness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jan 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Jafar, University of Jordan
- Investigators
- Dr Abdalla Awidi, MD, Study chair, Cell therapy center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815213
- Sponsor's protocol ID
- POF.UJCTC
- Status last verified
- Jan 2025
- First submitted
- 2 Mar 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT04815213
- Acronym / sponsor ID
- POF.UJCTC
- Conditions
- Premature Ovarian Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure
Detailed description
MSCs in passage-2 culture will be washed with PBS and detached with trypsin/EDTA (0.25%). After that, the cells will be suspended at a density of 20×106 cells/ 2 ml normal saline and loaded into 3 ml sterile syringes.
The cells should be infused within 2 hours of release. Tests and follow up are to be monthly.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MSCs Intravaginally | Experimental | Biological: expanded autologous bone marrow derived MSC IntravaginallyExpanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally |
| MSCs Laparoscopic | Experimental | Biological: expanded autologous bone marrow derived MSC LaporoscopicExpanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Laparoscopic |
| EV | Experimental | Biological: EVExtravascular vesicles (EV) injection |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent
- Married female, 18-38 years old
- Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 20 IU/L) and/or Primary or secondary amenorrhea at least for 6 months
- Evidence of low ovarian reserve defined as: AMH < _0.3 ng/ML \& FSH >20 IU/L, AFC < 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder).
- Normal karyotype 46, XX.
Key exclusion criteria (11 listed)
- Currently breast-feeding
- Has a history of, or evidence of current malignancy
- Major mental health disorder that precludes participation in the study
- Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed.
- Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expanded autologous bone marrow derived MSC IntravaginallyAlso: BM-MScAutologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary | Biological | MSCs Intravaginally |
| expanded autologous bone marrow derived MSC LaporoscopicAutologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary | Biological | MSCs Laparoscopic |
| EVExtracellular vesicles injection | Biological | EV |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12 months
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
3 secondary outcomes
Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes
Time frame: 12 months
Number of patients with positive ovarian changes
Time frame: 12 months
Number of patients with increased endometrial thickness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Ovarian Failure
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Abdalla Awidi, MD study chair
Cell therapy center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing expanded autologous bone marrow derived MSC Intravaginally, expanded autologous bone marrow derived MSC Laporoscopic and EV in people with Premature Ovarian Failure, run by University of Jordan at 1 site in Jordan.
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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. 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 Jordan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025.