Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04087889 |
| Other study ID # |
HBPC01 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
January 2020 |
| Source |
Hope Biosciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial 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.
Description:
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.,
- CMP,
- Coagulation Panel,
- TNF-a
- IL-6
- CA 19-9
- LDH
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
3. Weight
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.,
- CMP,
- Coagulation Panel,
- TNF-a
- IL-6
- CA 19-9
- LDH
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.
