Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04907188 |
| Other study ID # |
HBSK01 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
November 2022 |
| Source |
Hope Biosciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial Summary
This protocol is part of an Individual Patient Expanded Access IND. The patient is an
84-year-old male with history of Ischemic Stroke of the Left Middle Cerebral Artery causing
an acute posterior left frontal cortical infarct with petechial hemorrhage and mild local
mass effect without midline shift. The Stroke was due to a long-standing evolution of atrial
fibrillation that provoked an embolus. The original stroke event happened on
February/14/2022.
Description:
This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal
Stem Cells with the primary goal of treating 1 individual with Stroke who has exhausted all
current treatment options and whose condition has not improved. There are no FDA approved,
fully restorative treatments for his condition. We propose to administer 6 autologous
HB-adMSCs intravenous infusion of 200 million (2 x 10^8 cells) cells approximately every 28
days.
A protocol amendment to administer additional HB-adMSCs infusions/injections may be submitted
to IRB for approval depending on the patients' response, AE/SAEs, and cell expansion
characteristics.
This expanded access IND was created at the request of the subject and his physician. After
receiving approvals from Western IRB and FDA, the subject will be contacted and provided with
a copy of the informed consent for review. The PI will meet with the patient in person or by
telephone and explain the study procedures (including the HB-adMSCs administration), and
safety assessment procedures), follow-up visits, potential risks and benefits of the study,
alternatives, and the voluntary nature of participation. Ample time will be given for the
patient to ask questions and decide about participation. If consent is obtained, a schedule
of study events and a copy of the signed informed consent document will be provided to the
patient. The informed consent process will be documented in the appropriate Source Documents
and will include the discussion points mentioned above.
The subject will go through a screening process that will last up to 14 days. During this
time the Clinical Investigator will review labs and diagnostic test results to confirm study
eligibility. Abnormal test results (i.e., ongoing infection), may require follow-up before
proceeding with the treatment. This screening period will start with the "Screening Visit",
which will include the following procedures:
1. Informed Consent will be obtained.
2. Demographics
3. Review of inclusion and exclusion criteria
4. Review of medical history and concomitant medications
5. Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
6. Physical exam
7. Height and weight
8. Blood samples will be collected for safety assessments:
1. Hematology
2. Chemistry
3. Coagulation Panel
9. A verification of patient consent will be verbally performed.
10. Clinician Assessments: NIH Stroke Scale and The Barthel Index.
11. Patient Assessments SF36 and PHQ Depression Scale will be administered.
Infusion 1 (Week 1) Once the eligibility is confirmed, +7 days after the screening visit, the
subject will return to
HBSCRF to receive the IV treatment. Procedures will be assessed as follows:
1. Review of medical history, adverse events, and concomitant medications.
2. Physical exam
3. Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
4. A verification of patient consent will be verbally performed
5. The patient will wear an Apple watch during infusions to monitor heart rate.
6. The HB-adMSCs will be administered and the patient closely observed:
a. One intravenous infusion of HB-adMSCs (2x10^8 cells) to last 1 hour.
7. The subject will then be monitored for a minimum of 1hr after infusion as follows:
b. Measure Vital signs at minute 0 of the infusion c. Measure Vital signs at minute 15
after IV infusion. d. Measure Vital Signs at minute 30 after IV infusion. e. Measure
Vital signs at minute 60 after IV infusion. f. Measure Vital signs at minute 120 after
IV infusion. g. Vital signs will be recorded more frequently if clinically indicated).
8. The Subject will be given comprehensive discharge criteria/instructions.
9. Telephone encounter for adverse events. The subject will be contacted by telephone the
following day, and 72 hours later after the infusion visit to determine if any adverse
events have occurred. ** The Patient will be evaluated by his cardiologist post infusion
with a 12 lead EKG for any signs of significant cardiac changes that prevent the patient
from continuing to receive the product from a cardiac standpoint (post infusion 1) the
rest of the infusions will not be administered. However, the patient will be followed
until resolution of any adverse events.
Parameter Values Systolic blood pressure + 20% of baseline. Diastolic blood pressure + 20% of
baseline. Heart rate + 20% of baseline Temperature >96.7F and <100.5F Respiratory rate >10
breaths per minute and < 22 breaths per minute Pulse oximetry > 94% on room air Additionally,
the following will be documented to ensure a safe discharge from the research facility:
- The patient must be alert and oriented with normal mental status.
- The patient must be afebrile with vital signs within normal limits.
- The patient will be able to ambulate with little or minimal assistance.
- The patient will rate a level of pain at 3 or below on a scale of 0-10.
Week 2 to week 22, Infusions 2 to 6
1. Review of medical history, adverse events, and concomitant medications.
2. Physical exam
3. Vital signs (Heart Rate, Blood Pressure, Respirations, Temperature, SpO2)
4. PHQ-9 Depression Scale will be assessed at Screening, Infusion 6 and EOS
5. Adverse Events will be assessed during every visit from start to end
6. The patient will wear an Apple watch during infusions to monitor heart rate.
7. Clinician Assessments of the NIH Stroke Scale and Barthel Index will be recorded during
Infusion 4 and EOS.
8. Blood samples will be collected for safety and efficacy assessments:
1. Hematology
2. Chemistry
3. Coagulation Panel
9. The Subject will be given comprehensive discharge criteria/instructions.
10. Telephone encounter for adverse events. The subject will be contacted by telephone the
following day, and 72 hours later after the infusion visit to determine if any adverse
events have occurred. The Patient will be evaluated by his cardiologist post infusion #
2 with a 12 lead EKG for any signs of significant cardiac changes. ** If there are any
significant cardiac changes after the 2nd EKG that prevent the patient from continuing
to receive the product from a cardiac standpoint (post infusion 2) the rest of the
infusions will not be administered. However, the patient will be followed until
resolution of any adverse events.
Week 24- Follow Up Phone Call
The patient will receive a follow up phone call to assess the following:
1. Review and update medical history
2. Assess for adverse events
3. Update concomitant medications list
Week 52 - End of the study (EOS)
The patient will undergo an end of study visit at week 26 at HBSCRF that will include:
1. Review and update medical history
2. Update concomitant medications list
3. Weight measurement
4. Vital signs (Heart Rate, Blood Pressure, Respirations, Temperature, SpO2)
5. Physical exam
6. Blood samples will be collected for safety and efficacy assessments:
1. Hematology
2. Chemistry
3. Coagulation Panel
7. Clinician Assessments: NIH Stroke Scale and The Barthel Index will be recorded.
8. Patient Assessments: SF-36 and PHQ-9 self-assessments will be completed.
9. Adverse Event Monitoring
