IRCT20160704028786N2尚未招募1 期
DOPASON project: The Assessment of Safety and Feasibility of Intra-Striatal Transplantation of Human Embryonic stem cell-derived Dopaminergic Progenitors (DopaCell) in Parkinson’s disease: A Multicenter Phase I Clinical Trial
Iranian academic center for education culture and research0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
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
- 30 years 至 70 years（—）
- 性别
- All
入选标准
- •Definitive diagnosis of PD based on MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015)
- •The duration of the disease must be at least 5 years from the time of diagnosis
- •Patients should have ON- and OFF-period and have Hoehn Yahr stage=III during OFF-period and Hoehn Yahr stagePatients should only receive drug treatment at the time of study entry
- •The patient does not have levodopa-induced dyskinesia
- •The patient must have at least 30% response to levodopa therapeutic dose (based on UPDRS part III).
- •The function of different organs based on laboratory evaluations, within 7 days of entering the study, should include: (1) neutrophil count =2000/µl (2) platelet count =100,000/µl (3) AST/ALT =3 times the maximum normal value at the intervention site (4) total bilirubin value = 1.5 times the maximum normal value at the intervention site (5) eGFR level: greater than or equal to 60 ml/min/1.73 square meters.
- •Before entering the study, the patient must submit a written consent form to participate in the research. (If the patient is unable to write due to illness, the patient's legal guardian must complete the written consent form, or if the legal guardian is not present, the patient must verbally inform the researcher of consent to enter the study.)
排除标准
- •Patient with underlying disease (Such as abnormal immune system)
- •Patient with symptomatic brain damage confirmed by MRI
- •Patient with dementia.
- •Patient with a GBA mutation.
- •Patient with an abnormal coagulation system
- •Patient with positive viral markers.
- •Patient considered high-risk for surgical intervention (high risk of cardiovascular disease, pulmonary and other systemic diseases in pre-op evaluation)
- •Patient with concurrent neurological disorder such as malignancy, neoplasm, epilepsy, cerebral hemorrhage or a positive history of it, or uncontrolled mental diseases.
- •Patient with contraindications for MRI (the presence of metal in the body, the presence of a pacemaker in the body, claustrophobia, with artificial heart valves that are incompatible with MRI, body weight not within the tolerable range for the MRI table).
- •Patient cannot tolerate the use of immunosuppressive regimens (including azathioprine, prednisolone, tacrolimus), concomitant medications (such as levodopa, carbidopa, MRI contrast agent), cotrimoxazole, or bovine serum derivatives.
- •Patient that has undergone another cell transplantation.
- •Patient that is pregnant or lactating.
- •Patient who, according to the researcher's opinion, is not suitable for conducting the study safely.
- •Patient with a history of chronic alcohol or drug use.
- •Patient with a history of taking immunosuppressive drugs, antipsychotic drugs, anticonvulsant drugs, anticoagulant drugs, or apomorphine in the last three months.
- •Patient with a history of using botulism toxin, phenol, or any drug related to the treatment of dystonia or muscle cramps in the six months leading to the study.
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