Use Of Autologous Stem Cell Use In Neurological Non-neoplastic Disorders And Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Number of participant with adverse events (AE) or severe adverse events (SAE)
研究概览
简要总结
The study deals with evaluation of safety and efficacy of use of stem/stromal cell isolates from autologous microvasculature in neurological, non-neoplastic disease. Autologous cells are acquired via microcannula aspiration of subdermal fat deposits, isolated through a digestive process, and concentrated via standard centrifugation. The cellular stromal vascular fraction (cSVF) created is neutralized and rinsed to eliminate residual enzymatic molecules.
These cells are suspending in sterile Normal Saline Solution (500cc) and re-administered via an intravenous parenteral route, passed through a standard sterile 150 u (micron) filter in line.
Multiple tracking and questionnaire followup is intended over a 5 year period, with objective and subjective criteria being met. Compilation and analysis of data to be completed after that period.
详细描述
Dementia refers to neurodegenerative conditions causing gradual decrease in ability to think and recall, to the point that is impacts daily functions. It is often accompanied by language difficulties, wide ranging emotional issues, loss of language skills, and lowering of activity motivation. These changes are often in the face of unchanged consciousness.
Most common type is Alzheimer's Disease (50-70% of cas.es), but include vascular dementia (25%), Lewy Body dementia (15%) and frontotemporal dementia. There are many interrelated disorders that mask the underlying issues, such as in Parkinson's Disease, and whose diagnosis may overlap with the others.
Most common symptoms include memory lapses, visual-spatial language changes, attention loss and problem solving difficulties. A wide variety of other symptoms may be seen, such as balance issues, tremors, difficulty swallowing, hallucinations, wandering, restlessness or agitation/depression, mood swings, etc..
Parkinson's Disease (PD) is a long-term neurodegenerative disorder of the Central Nervous System (CNS) that usually impacts the motor system, in a progressive and long-term fashion. Early signs include tremors, rigidity, slow movements and walking issues. It is often associated with thinking problems and depression, plus emotional states that impact daily living.
The causation of PD is felt to involve genetic predisposition and environmental factors. History of head injuries, chemical exposures, smokers, caffeine intake and other dietary issues. The motor symptoms seem to result from cellular death in the midbrain area (particularly the substantia nigra) and associated with inadequate dopamine. Plaques (protein build up following cellular death) may be a prominent feature, and use of neuroimaging (like MRI with/without contrast) is of value to track progressive changes in the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented Functional Neurological Damage To Central or Peripheral Nervous System Unlikely To Improve With Present Standard of Care Approaches
- •At least 6 months after onset or diagnosis of disease process
- •Current Medical therapy for the condition is either failing or not tolerated by patient
- •Patient must be capable of interval neurologic exams with investigators or their own neurologic specialists
- •Patient must be capable and determined competent to provide detailed informed consent for study participation
- •In estimation of investigators, that there are minimal or no significant risk of harm to general health or conditions for collection of autologous stem cell collection and use
排除标准
- •Inability of patient to have diagnostic examinations or studies (MRI) to evaluate and document the disease state or unwilling/unable to cooperate with such documentation
- •Patients not medically stable, or whom may have ongoing conditions which increases may place the patient at significant risk of major complications, to be determined by investigator or patient's medical provider or neurologic specialists
- •History of active cancer or ongoing anticancer therapy within six months of such care
- •Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant of at minimum of 3 month after study treatment
研究组 & 干预措施
Centricyte 1000
Autologous Adipose-Derived Tissue Stromal Vascular Fraction (tSVF) via enzymatic digestive isolation & concentration in Centricyte 1000 closed system to create AD-cSVF
干预措施: Centricyte 1000 (Device)
Sterile Normal Saline Infusion
Sterile Normal Saline to Re-Suspend Autologous cSVF pellet for delivery via intravascular (IV) route
干预措施: Sterile Normal Saline Infusion (Procedure)
Microcannula Harvest Adipose
Acquisition AD-tSVF Via Closed Syringe Microcannula
干预措施: Microcannula Harvest Adipose (Procedure)
结局指标
主要结局
Number of participant with adverse events (AE) or severe adverse events (SAE)
时间窗: 6 month intervals for up to 5 years
Activities of Daily Living (ADL)
次要结局
- Magnetic Resonance Imaging (MRI)(6 month intervals for up to 5 years)
- Neurological Function(6 month Intervals for up to 5 years)
- Neurological Tested Functions(6 month interval for up to 5 years)
研究者
Ryan Welter, MD, PhD
Principal Investigator, Science
Healeon Medical Inc