The Use of Expanded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans: Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
Autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
MSCs Intravaginally
Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Inravaginally
干预措施: expanded autologous bone marrow derived MSC Intravaginally (Biological)
MSCs Laparoscopic
Expanded autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary Laparoscopic
干预措施: expanded autologous bone marrow derived MSC Laporoscopic (Biological)
EV
Extravascular vesicles (EV) injection
干预措施: EV (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 12 months
Treatment adverse events are defined by any adverse event leading to hospitalization, organ failure or death
次要结局
- 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)
研究者
Hanan Jafar
Vice director/ Cell therapy center
University of Jordan