NCT04815213

Brief Summary

Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
9mo left

Started Jan 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

March 2, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

March 2, 2021

Last Update Submit

January 23, 2025

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (3)

  • Number of patients with enhanced hormonal profile, ovarian changes and endometrial changes

    12 months

  • Number of patients with positive ovarian changes

    12 months

  • Number of patients with increased endometrial thickness

    12 months

Study Arms (3)

MSCs Intravaginally

EXPERIMENTAL

Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally

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

Biological: expanded autologous bone marrow derived MSC Laporoscopic

EV

EXPERIMENTAL

Extravascular vesicles (EV) injection

Biological: EV

Interventions

expanded autologous bone marrow derived MSC IntravaginallyBIOLOGICAL

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

Also known as: BM-MSc
MSCs Intravaginally
expanded autologous bone marrow derived MSC LaporoscopicBIOLOGICAL

Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

MSCs Laparoscopic
EVBIOLOGICAL

Extracellular vesicles injection

EV

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMarried female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center, University of Jordan

Amman, Jordan

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Dr Abdalla Awidi, MD

    Cell therapy center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director/ Cell therapy center

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 24, 2021

Study Start

January 1, 2022

Primary Completion

January 31, 2025

Study Completion (Estimated)

January 31, 2027

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

JO(1)