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

Premature Ovarian Failure Clinical Trial

Official title:

The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815213
• Other study ID #: POF.UJCTC
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2021
• Source: University of Jordan
• Contact: Dr Hanan Jafar, PhD
• Phone: +96798871087
• Email: hanan.jafar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• expanded autologous bone marrow derived MSC
Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary

Locations

Country	Name	City	State
Jordan	Cell Therapy Center, University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of patients with positive ovarian changes	Patients ultrasounds of the ovaries will compare size and follicle numbers	12 months
Secondary	Number of patients with increased endometrial thickness	Ultrasounds of uterus will be compared for endometrial thickness	12 months