Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis
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
The drug for this submission is Hope Biosciences' autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Amyotrophic Lateral Sclerosis (ALS). Stem cells have become a promising tool for the treatment of inflammatory and neurodegenerative conditions, including autoimmune diseases, traumatic brain injury, Parkinson's disease, and Alzheimer's disease.
详细描述
Once the eligibility is confirmed, approximately 1-2 weeks after the screening visit, the subject will return for the baseline/first infusion visit. Subsequent treatments will occur 2 weeks apart for 18 weeks, for a total of 10 infusions. Follow-up visits will occur at 22 weeks, 26 weeks and 39 weeks. End of study visit will occur at 52 weeks.
Baseline/Infusion 1 Visit
- A verification of patient consent will be verbally performed and included in the progress note.
- Review of medical history, and concomitant medications.
- Physical exam + ALS Functional Rating Scale-Revised (ALSFRS-R)
- Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
- Weight measurement
- Blood samples will be collected for safety and efficacy assessments:
- Hematology
- Chemistry
- Coagulation Panel
- Proinflammatory Cytokines (IL-2, IL-6, TNF-a)
- C- Reactive Protein (CRP)
- The HB-adMSCs will be administered and the patient closely observed:
• One intravenous infusion of HB-adMSCs (2x108 cells) to last 1 hour:
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Amyotrophic Lateral Sclerosis.
- •Capable of giving informed consent (signed, verbal or assent as applicable and as listed in the protocol)
排除标准
- •Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
- •Any abnormal, inexplicable laboratory result that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
- •Participation in other interventional research studies within the past 30 days.
- •Unwillingness to return for follow-up visits.