Individual Patient Expanded Access IND of Hope Biosciences Allogeneic First Blood Relative Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Pancreatic Cancer
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' allogeneic, first blood relative, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Pancreatic Cancer (PC). PC is an extremely infiltrative neoplasm that usually presents with vascular and perineural invasion in surgically resected tumors. Metastases to lymph nodes, liver and distant sites are all very common. Its incidence has markedly increased over the past several decades and ranks as the fourth leading cause of cancer death in the United States. Despite the high mortality rate associated with pancreatic cancer, its etiology is poorly understood. PC patients experience physiological symptoms such as anemia, ascites, severe fatigue, pain, cachexia, weakness, insomnia, confusion, and memory loss. The aggressive nature of PC leads to rapid deterioration of patients' quality of life and diminished ability to participate in treatment.
详细描述
Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline visit, the subject will return for the first infusion. Subsequent treatments will occur weekly for the first 8 infusions, followed by 4 infusion that occur 2 weeks apart. The total number of infusions will be 12.
On each of these visits, the subject will receive one allogeneic HB-adMSC infusion of 200 million (2 x 10^8 cells) total cells suspended in 250 mL normal saline for IV infusion. Every infusion visit will include the following procedures:
- Review of medical history,
- Complete Physical exam (Week 1, 4, 10, 20, and 52),
- Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
- Weight measurement
- A verification of patient consent will be verbally performed
- *When applicable (Week 4, 7, 10, 14, 20 and 52): A urine and blood sample for clinical labs including:
- CBC with diff.,
- CMP,
- Coagulation Panel,
- TNF-a
- IL-6
- CA 19-9
- LDH
- The HB-adMSC infusion will be given via IV.
- The subject will then be monitored for a minimum of 2hr after infusion.
- 24-hour telephone assessment for adverse events
- Video Documentation
Vital signs will be continuously monitored during the infusion and recorded at 15 minutes intervals during the first hour. Vital signs will be recorded at the end of the infusion and every 30 minutes x 2 hours or more frequently if clinically indicated. The subject will be contacted by telephone 24hr. after the infusion visit to determine if any adverse events have occurred.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Pancreatic Cancer
- •Hemodynamically stable
排除标准
- •Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
- •Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration.
- •Any abnormal, inexplicable laboratory result with no obvious cause defined.
- •Participation in other interventional research studies. Unwillingness to return for follow-up visits