The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans

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

Study Overview

• Status: Recruiting
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Biological: expanded autologous bone marrow derived MSC

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr Hanan Jafar, PhD; Phone Number: +96798871087; Email: hanan.jafar@gmail.com

Study Locations

• Jordan
  • Amman, Jordan
    • Recruiting
    • Cell Therapy Center, University of Jordan
    • Contact: Abdullah Aweidi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Signed and dated informed consent
2. Married female, 18-38 years old
3. 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
4. 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).
5. Normal karyotype 46, XX.
6. Presence of at least one ovary
7. Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels.
8. Agree to report any pregnancy to the research staff immediately.
9. Cooperative patient
10. Negative for infectious panel (HIV, HBV, HCV, and VDRL)

Exclusion Criteria:

1. Currently breast-feeding
2. Has a history of, or evidence of current malignancy
3. Major mental health disorder that precludes participation in the study
4. 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.
5. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications
6. Significant anemia (Hemoglobin <8 g/dL).
7. Untreated deep venous thrombosis, and/or pulmonary embolus
8. Known heart disease (New York Heart Association Class II or higher).
9. Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL).
10. Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL).
11. Clinically active autoimmune condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary	Biological: expanded autologous bone marrow derived MSC; Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary; Other Names: BM-MSc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
Number of patients with positive ovarian changes	Patients ultrasounds of the ovaries will compare size and follicle numbers	12 months
Number of patients with increased endometrial thickness	Ultrasounds of uterus will be compared for endometrial thickness	12 months

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Study Chair: Dr Abdalla Awidi, MD, Cell Therapy Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ANTICIPATED): January 31, 2022
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: POF.UJCTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No