Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04604288 |
| Other study ID # |
HBKP01 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
July 2022 |
| Source |
Hope Biosciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial Summary
This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal
Stem Cells with the primary goal of treating 1 individual with bilateral knee pain who has
exhausted all treatment options, his condition has not improved, and his quality of life is
severely affected by the condition. There are no FDA approved, fully restorative treatments
for his condition. The subject will receive 2 autologous HB-adMSCs intravenous infusion of
200 million (2 x 10^8 cells) total cells, and 4 autologous HB-adMSCs intra-articular
injections (1 in each knee joint/ intervention).
Description:
- Screening Visit Week 0 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. Physical exam
6. Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
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.
- Intervention 1 Day 1 (Week 1) and Intervention 2 Day 1 (Week 12) 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. Patient pain assessment VAS of Pain
4. Patient pain assessment WOMAC Knee Score
5. Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2)
6. Weight measurement
7. A verification of patient consent will be verbally performed
8. The HB-adMSCs will be administered and the patient closely observed:
a. One intravenous infusion of HB-adMSCs (2x108 cells) to last 1 hour:
1. Volume: 250 ml
2. Rate: 4-5 mls/min (250ml/h)
9. The subject will then be monitored for a minimum of 1hr after infusion as follows:
1. Measure Vital signs at minute 0 of the infusion
2. Measure Vital signs at minute 15 after IV infusion.
3. Measure Vital Signs at minute 30 after IV infusion.
4. Measure Vital signs at minute 60 after IV infusion.
5. Measure Vital signs at minute 120 after IV infusion.
6. Vital signs will be recorded more frequently if clinically indicated).
10. The Subject will be given comprehensive discharge criteria/instructions.
11. Telephone encounter for adverse events. The subject will be contacted by telephone the
following day after the infusion visit to determine if any adverse events have occurred.
* Post infusion discharge criteria Immediately following the completion of each
infusion/injection, the subject should be assessed to ensure that the post-infusion
discharge criteria have been met.
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 mentation 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.
- Intervention 1 Day 2 (Week 1) and Intervention 2 Day 2 (Week 12) 24 hours
after the IV infusion the subject will go to the PI's clinic office to receive
the intra- articular injections.
a. Review of medical history, adverse events, and concomitant medications. b.
Vital signs (Heart Rate, Blood Pressure, Respirations, Temp., SpO2) c. Knee
MRI without contrast at IA injection 1. If a Knee MRI without contrast has
been performed in the last 14 days, it can be used as a baseline and compared
with the following Knee MRI without contrast.
d. The HB-adMSCs will be administered and the patient closely observed:
a. One ultrasound-guided intra-articular injection in the right knee with
1x108 cells/2ml.
b. One ultrasound-guided intra-articular injection in the left knee with 1x108
cells/2ml.
e. The subject will then be monitored for a minimum of 30 minutes after the
injections as follows:
a. Measure Vital signs at minute 0 of infusion. b. Measure Vital signs at
minute 15 after IV infusion. c. Measure Vital Signs at minute 30 after IV
infusion. d. (Vital signs will be recorded more frequently if clinically
indicated). f. The Subject will be given comprehensive discharge
criteria/instructions. g. Blood samples will be collected for safety
assessments:
a. Hematology b. Chemistry c. Coagulation Panel h. Telephone encounter for
adverse events. i. The subject will be contacted by telephone the following
day after the infusion visit to determine if any adverse events have occurred.
- Post injection discharge criteria Immediately following the completion of
each infusion/injection, the subject should be assessed to ensure that
the post-infusion discharge criteria have been met.
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 mentation
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.
-Weeks 3 and 14 - Follow Up Visits
The patient will be assessed for adverse events 24 hours after each injection with a
follow up phone call. The patient will also undergo a thorough on-site follow up visit
at the infusion site (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, Temp., SpO2)
5. Physical exam
6. Blood samples will be collected for safety assessments*
a. Hematology b. Chemistry c. Coagulation Panel
7. Patient pain assessment - Visual Analog Scale
8. WOMAC Knee Score
9. Adverse event monitoring * Safety labs will not be collected at Follow UP Week 14
-Week 18 - End of the study (EOS)
The patient will undergo an end of study visit at week 18 at the PI's office 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, Temp., SpO2)
5. Physical exam
6. Blood samples will be collected for safety and efficacy assessments:
1. Hematology
2. Chemistry
3. Coagulation Panel
7. Knee MRI without contrast
8. Patient pain assessment - Visual Analog Scale
9. WOMAC Knee Score
10. Adverse Event Monitoring
