NL-OMON49256撤回2 期
A Phase 2a, Open-label, Multicenter Study to Evaluate Safety and Tolerability of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in Participants with Prodromal to Mild Alzheimer*s Disease - BCT-201-E
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Males and females, ages 50 to 75 years old, inclusive, at the Screening
- •Visit (Visit 1).
- •2. Clinical diagnosis of prodromal to mild AD at least 6 months prior to
- •enrollment, based on the International Working Group (IWG-2) diagnostic
- •criteria or the National Institute on Aging-Alzheimer's Association (NIA-AA)
- •diagnostic criteria.
- •3. Mini Mental State Examination (MMSE) of 20-30, inclusive, and Clinical
- •dementia rating-global score (CDR-GS) of 0.5 or 1.0
- •4. Demonstrated abnormal memory function
- •5. CSF profile consistent with AD: Amyloid Beta 42 (A*42) concentration of
- •<1000 pg/ml AND P-tau >19 pg/ml or ratio of p-tau/Abeta > 0.024 (Elecsys assay)
- •6. If currently treated with Cholinesterase Inhibitors (AChEI) (donepezil,
- •galantamine, or rivastigmine) or Memantine the dose should be stable for at
- •least 12 weeks prior to Screening (Visit 1).
- •7. Must have a caregiver that is willing to participate in the study and is
- •able to provide accurate information on the participant's cognitive and
- •functional ability.
- •8. Must consent to apolipoprotein E (ApoE) genotyping or willing to provide
- •previous test results.
- •9. If sexually active and of childbearing potential, both females and males
- •must agree to use an effective birth control method during the study and for at
- •least 3 months following the last transplantation, such as: abstinence,
- •intrauterine device (IUD), oral contraception, barrier and spermicide or
- •hormonal implant.
排除标准
- •1. Prior stem cell therapy of any kind.
- •2. Active participation in any other interventional study or use of unapproved
- •AD investigational therapy within 60 days prior to the Screening Visit (Visit
- •1), unless proven to have been on placebo.
- •3. Inability to lie flat for the duration of intrathecal cell administration
- •and/or bone marrow aspiration, or inability to tolerate study procedures for
- •any other reason.
- •4. History of clinically significant autoimmune disease (excluding thyroid
- •disease) that may confound study results, myelodysplastic or myeloproliferative
- •disorder, leukemia or lymphoma, whole body irradiation, hip fracture, or severe
- •5. Any poorly controlled clinically significant medical condition other than
- •Alzheimer*s disease (e.g., within six months of Screening Visit (Visit 1), such
- •as myocardial infarction, angina pectoris, congestive heart failure, or
- •hypertension (repeated blood pressure >180 mmHg systolic or 100 mmHg diastolic)
- •as well as clinically significant coagulopathy, treatment with anticoagulants
- •that, in the opinion of the investigator, would compromise the safety of
- •participants.
- •6. Any history of malignancy (e.g., myeloproliferative disorder, leukemia or
- •lymphoma) within the previous 5 years, except for non-melanoma localized skin
- •cancers (with no evidence of metastasis, significant invasion, or re-occurrence
- •within three years of Screening Visit (Visit 1)).
- •7. Any history of acquired or inherited immune deficiency syndrome.
- •8. Platelet count, INR, PT or PTT not within the normal range (local protocol)
- •or other risk for increased or uncontrolled bleeding (safety for lumbar
- •puncture and bone marrow).
- •9. Presence of contraindication to lumbar puncture as judged by local PI, e.g.
- •need for anticoagulant or antiplatelet medications other than aspirin at a dose
- •of * 100 mg/day or clopidogrel.
- •10. MRI evidence of a) more than three lacunar infarcts, b) territorial infarct
- •or macroscopic hemorrhage, or c) deep white matter lesions (corresponding to a
- •Fazekas score of 3).
- •11. Pregnant women or women currently breastfeeding.
- •12. Positive test result for Hepatitis B virus (HBV; surface antigen (HBsAg)
- •and antibodies to core antigen (IgG and IgM anti-HBc)), Hepatitis C virus
- •(HCV), Human Immune deficiency Virus (HIV) 1 and 2.
- •13. Any medical or neurological/neurodegenerative condition other than AD
- •(e.g.,vascular dementia, dementia with Lewy bodies, and Parkinson*s disease)
- •that, in the opinion of the Investigator, might be a contributing cause to the
- •participant's cognitive impairment or could lead to discontinuation, lack of
- •compliance, interference with study assessments, or safety concerns (includes,
- •low vitamin B12 level, low Hb level (<100); hypothyroid disease).
- •14. History within the past 6 months or evidence of clinically significant
- •psychiatric illness (e.g., major depression, suicidality, schizophrenia, or
- •bipolar affective disorder).
- •15. Any condition, which in the opinion of the investigator or the Sponsor
- •makes the patient unsuitable for inclusion.
研究者
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