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

Primary Purpose

Premature Ovarian Failure

Status

Unknown status

Phase

Phase 1

Locations

Jordan

Study Type

Interventional

Intervention

expanded autologous bone marrow derived MSC

About this trial

This is an interventional other trial for Premature Ovarian Failure

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Cell Therapy Center, University of JordanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of patients with positive ovarian changes

Patients ultrasounds of the ovaries will compare size and follicle numbers

Number of patients with increased endometrial thickness

Ultrasounds of uterus will be compared for endometrial thickness

Full Information

NCT ID

NCT04815213

First Posted

March 2, 2021

Last Updated

March 22, 2021

Sponsor

University of Jordan

1. Study Identification

Unique Protocol Identification Number

NCT04815213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

January 31, 2022 (Anticipated)

Study Completion Date

January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Ovarian Failure

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

expanded autologous bone marrow derived MSC

Other Intervention Name(s)

BM-MSc

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Efficacy will be measured comparing hormonal changes (FSH, LH, AMH, estradiol) in patients' blood on monthly intervals

Time Frame

12 months

Title

Number of patients with positive ovarian changes

Description

Patients ultrasounds of the ovaries will compare size and follicle numbers

Time Frame

12 months

Title

Number of patients with increased endometrial thickness

Description

Ultrasounds of uterus will be compared for endometrial thickness

Time Frame

12 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Married female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dr Hanan Jafar, PhD

Phone

+96798871087

hanan.jafar@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Abdalla Awidi, MD

Organizational Affiliation

Cell therapy center

Official's Role

Study Chair

Facility Information:

Facility Name

Cell Therapy Center, University of Jordan

City

Amman

Country

Jordan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abdullah Aweidi, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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