Track topics on Twitter Track topics that are important to you
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.
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:
1. Review of medical history,
2. Complete Physical exam (Week 1, 4, 10, 20, and 52),
3. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
4. Weight measurement
5. A verification of patient consent will be verbally performed
6. *When applicable (Week 4, 7, 10, 14, 20 and 52): A urine and blood sample for clinical labs including:
- CBC with diff.,
- Coagulation Panel,
- CA 19-9
7. The HB-adMSC infusion will be given via IV.
8. The subject will then be monitored for a minimum of 2hr after infusion.
9. 24-hour telephone assessment for adverse events
10. 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.
*Please note that blood and urine sample during the intervention period will only be required for the visits corresponding to weeks 4, 7, 10, 14, 20 and 52. During these visits, these samples will always be taken before the infusion is started. Refer to Table 1. Schedule of assessments for more details.
Follow-up Visits week 4,7, 10, 14, 20, and 52
The subject will undergo the following procedures at each follow-up visit without infusion:
1. Review and update medical history,
2. Update concomitant medications list
4. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
5. Complete physical exam (Week 1, 4, 10, 20, and 52)
6. A urine and blood sample for clinical labs including:
- CBC with diff.,
- Coagulation Panel,
- CA 19-9
7. Adverse event monitoring.
In addition, visits 13 and 14 (week 20 and 52) will include CT Scans of the chest, abdomen and pelvis. This procedure could be done up to 7 days before or after the actual visit day, depending on availability and schedule of the imaging center. If a CT Scan has been done as standard of care within 30 days of these visits, it would meet the requirement for this assessment.
Hope Biosciences Allogeneic, First Blood Relative Adipose-Derived Mesenchymal Stem Cells
Published on BioPortfolio: 2019-09-18T03:27:45-0400
Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment fo...
The drug for this submission is Hope Biosciences' autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSC's) for the treatment of a single patient with Parkinson's Di...
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia i...
The objective of this study is to assess the safety and feasibility of allogeneic adipose tissue-derived mesenchymal stem cells (ASCs) injected into the lacrimal gland in a smaller groups ...
The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC_ASC) investigational medicinal product, to improve myocardial functio...
Allogeneic transplantation of induced pluripotent stem cell (iPSC)-derived cardiomyocytes is apromising treatment for cardiac diseases, although immune rejection by the recipient poses a concern. In t...
The human obese subcutaneous adipose tissue (SAT) contributes to systemic and B cell intrinsic inflammation, reduced B cell responses, and increased secretion of autoimmune antibodies. Immune cells ar...
The third-party umbilical cord blood (UCB)-derived regulatory T cells (Treg) are an alternative to donor-derived Treg as cellular therapy of graft-versus-host disease following hematopoietic stem cell...
Viral reduction and inactivation of cell-derived biologicals is paramount for patients' safety and so viral reduction needs to be demonstrated to regulatory bodies in order to obtain marketing authori...
Perianal fistulas are common in patients with Crohn´s disease (CD). Injections of cultured autologous and allogeneic adipose tissue-derived stem cells have been shown to heal CD-associated fistulas. ...
Specialized connective tissue composed of fat cells (ADIPOCYTES). It is the site of stored FATS, usually in the form of TRIGLYCERIDES. In mammals, there are two types of adipose tissue, the WHITE FAT and the BROWN FAT. Their relative distributions vary in different species with most adipose tissue being white.
The treatment of patients without the use of allogeneic BLOOD TRANSFUSIONS or blood products.
Brown fat-like adipose tissue that develops in WHITE ADIPOSE TISSUE from non-MYOGENIC REGULATORY FACTOR 5 expressing cell lineage.
Belief in a positive outcome.
Coded listings of physician or other professional services using units that indicate the relative value of the various services they perform. They take into account time, skill, and overhead cost required for each service, but generally do not consider the relative cost-effectiveness. Appropriate conversion factors can be used to translate the abstract units of the relative value scales into dollar fees for each service based on work expended, practice costs, and training costs.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Track and monitor developments in stem cell research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on stem cells and follow companies active in the stem cell industry. BioPort...