An Intermediate Size Patient Population Expanded Access IND to Evaluate the Safety of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This Expanded Access IND is to evaluate the safety of multiple intravenous administrations of HB-adMSCs for treating Parkinson's disease in 10 patients between 76 and 95 y/o who do not qualify for other investigations.The dose to use for this expanded access is 200 million HB-adMSCs, administered through intravenous infusion only, with a treatment duration of 18 weeks. The program includes an up to 28 days screening period, an 18-week Treatment Period, and a 6-week Safety Follow-up Period.
详细描述
This expanded access program is designed to include adult male and female outpatients with Parkinson's disease with ages between 76 and 95 y/o.
-Screening During the Screening Visit, each patient who participates in the expanded access program must sign an informed consent form that the IRB has approved before any related procedures can be performed.
In addition to completing the informed consent process, the designated personnel are responsible for conducting the evaluations listed in the Schedule of Assessments. These evaluations include the following:
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Collection of vital signs, demographic information, and concomitant medications.
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Evaluation of the eligibility requirements for participation in the expanded access program.
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Weight and height measurements.
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Lab sample collection. (Comprehensive Metabolic Panel, Complete Blood Count & Coagulation Tests).
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Physical examination.
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Parkinson's disease assessments. (MDS-UPDRS, PDQ-39, PFS-16, PHQ-9, and VAS). Once these assessments have been performed and the results of laboratory tests have been obtained, the principal investigator must evaluate whether the screened patient is eligible to participate in the expanded access program. If a participant meets the eligibility requirements for participation in the expanded access program, infusion number 1 (the baseline visit) must be scheduled.
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Infusions Every patient who qualifies for participation in the expanded access program will be invited to receive autologous HB-adMSCs infusions. The administration of investigational products will take place at the Hope Biosciences Stem Cell Research Foundation, where the delegated personnel will closely monitor patients' vital signs.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 76 Years 至 95 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
