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

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ClinicalTrials.gov Identifier: NCT04087889
Expanded Access Status : No longer available
First Posted : September 12, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hope Biosciences

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Drug: Hope Biosciences Allogeneic, First Blood Relative Adipose-Derived Mesenchymal Stem Cells

  Show Detailed Description

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



Intervention Details:
  • Drug: Hope Biosciences Allogeneic, First Blood Relative Adipose-Derived Mesenchymal Stem Cells
    Culture-expanded, adipose-derived mesenchymal stem cells donated by first blood relative
    Other Name: HB-adMSCs

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Criteria

Inclusion Criteria:

  1. Documented diagnosis of Pancreatic Cancer
  2. Hemodynamically stable

Exclusion Criteria:

  1. Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
  2. 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.
  3. Any abnormal, inexplicable laboratory result with no obvious cause defined.
  4. Participation in other interventional research studies. Unwillingness to return for follow-up visits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087889


Locations
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United States, Texas
Hope Biosciences
Sugar Land, Texas, United States, 77478
Sponsors and Collaborators
Hope Biosciences

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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04087889     History of Changes
Other Study ID Numbers: Pancreatic Cancer
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by Hope Biosciences:
Cancer
Pancreas
Adenocarcinoma
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases