Individual Patient Expanded Access IND of Hope Biosciences First Blood Relative Allogeneic Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Pancreatic Cancer

NCT04087889 | Unknown

• 1 other identifier: HBPC01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Cancer; Pancreas; Adenocarcinoma

Interventions

HB-adMSCs BIOLOGICAL

Culture-expanded, adipose-derived mesenchymal stem cells donated by first blood relative

Eligibility Criteria

• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of Pancreatic Cancer
• Hemodynamically stable

You may not qualify if:

• 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

Sponsors & Collaborators

• Hope Biosciences LLC: lead

Study Sites (1)

Hope Biosciences

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)