Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Socialization Alterations
研究概览
简要总结
Autism spectrum disorder (ASD) is a neurodevelopmental condition with core deficits in social communication and behavior, often accompanied by gastrointestinal (GI) and metabolic dysfunction. Emerging evidence supports the role of neuroinflammation (including autoimmune components), gut-brain axis disruption, and metabolic dysregulation in ASD pathophysiology. Multimodal interventions targeting these pathways-using autologous cSVF, cryopreserved MSCs, FMT, and dietary modulation-intent is that these multimodal interventions may offer synergistic benefits for adolescents and adults with ASD.
详细描述
This refined protocol integrates the latest evidence for a multimodal intervention-autologous cSVF, cryopreserved autologous MSCs, FMT, and a structured ketogenic protocol program-for adolescent and adult ASD management.
- Protocol Summary
Title:
A Phase 1-2 Randomized Controlled Trial Evaluating the Safety and Efficacy of Multimodal Therapy (Autologous cSVF + Cryopreserved Autologous MSCs, Fecal Microbiota Transplantation, Ketogenic Program Reset, and OT/PT Training) in Adolescents and Adults with Autism Spectrum Disorder (ASD-Multi-level scoring)
Sponsor: Blacktie Principal Investigator: Robert W. Alexander, MD, FICS Study Phase: Phase I/II Study Centers: 1-3 Clinical Applied Research Laboratories/academic centers with expertise in ASD, stem cell processing and utilization, plus gastroenterology/PMD consultants available for FMT in patient's locale
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable on current medications or therapy
- •With/wthout comorbid GI (gut/Axis) symptoms
排除标准
- •Recent antiobiotics or probiotic therapy within 30 days
- •Severe GI disease or malnutrition
- •Recent major surgery that may interfere with study course
- •Other Med/Surgery issues that may preclude treatment with this protocol
- •Inability to perform the monitoring of FMT without supervision by qualfied Provider
研究组 & 干预措施
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: Autologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells (Procedure)
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: Fecal Biomicrome Transplantation (FMT) (Dietary Supplement)
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: Ketogenic RESET Diet Protocol (Dietary Supplement)
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients (Behavioral)
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: FMT (Fecal Material Tranplantation) (Dietary Supplement)
ASD behavior, learning, communication and diet
diet, bowel flora, autoimmune tracking, cSVF/MSC (cryo) multimodal approach
干预措施: Use autologous cSVF + MSCs (cryo) for management of autoimmune component, anti-inflammatory and immune modulation (Biological)
结局指标
主要结局
Socialization Alterations
时间窗: 1 year
SRS-2 caregiver/teacher: Change in social behavior as measured by the Social Responsiveness Scale, Second Edition (SRS-2), a 65-item caregiver- and teacher-reported instrument scored on a scale of 0 to 195, where lower scores indicate better social functioning. SRS-2 assessments are completed at baseline, 3 months, 6 months, and 12 months to evaluate change over time.Time Frame: Baseline, 3 months, 6 months, and 12 months
Communication/Education Enhancement
时间窗: Months and 1 year
PPVT-5 Peabody Picture Vocabulary testing: Change in receptive vocabulary and language comprehension as measured by the Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5). Standard scores range from approximately 40 to 160 (mean = 100, SD = 15), where higher scores indicate better vocabulary and language ability. Testing is administered at baseline, 3 months, 6 months, and 12 months.Time Frame: Baseline, 3 months, 6 months, and 12 months
次要结局
- Gut-Brain Axis Improvement(1 year)