Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04711811 |
| Other study ID # |
HBCMP01 |
| 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 providing multiple administrations of
HBadMSCs for the treatment of Chronic Musculoskeletal Pain. The study duration is
approximately 32 weeks, during that time the study subject will complete 1 screening visit, 6
infusion visits, one follow-up visit without infusion and one end of study visit. Next day
telephone follow-up visits will occur following each infusion. Efficacy and safety labs as
well as quality of life and VAS scores will be obtained.
Description:
Visit 1 - Screening During the screening visit, the principal investigator and/or delegated
staff must provide a copy of the IRB-approved informed consent form * to the subject before
performing any study procedure.
* IRB must provide a certificate action as proof of approval of the informed consent form.
The study subject should take enough time to read this essential document. If the study
subject agrees to participate in the clinical trial, after reading the document, he/she must
sign it. By giving his/her signature, study subject allows the principal investigator and/or
designated staff to perform the following study procedures:
1. Collection of Medical History.
2. Collection of prior (up to a week before screening) and current medications.
3. Evaluation of Inclusion and Exclusion Criteria.
4. Measurement of Weight in lb. and Height in cm.
5. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
6. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete
Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation
rate.
7. Physical Examination by the principal investigator.
8. Video documentation of the subject walking and expressing the level of pain he/she
presents at that visit.
Visits 2, 3, 4, 6 and 7. (Infusions 1, 2, 3, 5 and 6) Throughout these visits, the principal
investigator and/or delegated staff will perform the following assessments:
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Completion of study questionaries by the subject.
6. Physical Examination by the principal investigator.
7. Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million
8. Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first hour
(0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).
9. 24 hours telephone encounter after Investigational Product Administration to assess
incidence of adverse events or serious adverse events.
10. Adverse Events monitoring.
Visit 5 (Infusions 4)
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete
Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation
rate.
6. Completion of study questionaries by the subject.
7. Physical Examination by the principal investigator.
8. Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million
- Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first
hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).
9. 24 hours telephone encounter after Investigational Product Administration to assess
incidence of adverse events or serious adverse events.
10. Adverse Events monitoring.
Visit 8 - Phone call Follow Up 1
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Adverse Events monitoring.
TREATMENT EXTENSION
After the study subject has completed Visit 7 - Infusion 6, the Principal Investigator will
analyze the patient's data to determine if the next series of infusions should be provided.
The criteria for making this conclusion are as follows:
- The patient must continue to meet inclusion/exclusion criteria for the study.
- The patient must be experiencing pain as evidenced by the VAS for pain.
- The patient must still be having difficulty in daily physical activities as evidenced by
SF36 questionnaire.
- The patient must sign a new informed consent for treatment (s) extension.
Before leaving the infusion center, if the subject is authorized to receive the requested
treatment extension, the subject must meet the following discharge criteria:
- Able to ambulate
- Respiration non-labored.
- Alert, oriented.
- SpO2 > 94 % on room air.
- SBP 100 to 139 mmHg & DBP 60 to 89 mmHg
- Heart Rate within normal limits (60 to 100 beats per minute)
Visits 9 and 15 (Infusion 7 and 12)
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete
Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation
rate.
6. Completion of study questionaries by the subject.
7. Physical Examination by the principal investigator.
8. Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million
- Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first
hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).
9. 24 hours telephone encounter after Investigational Product Administration to assess
incidence of adverse events or serious adverse events.
10. Adverse Events monitoring.
Visits 10, 11, 13, 14, 16 and 17 (Infusions 8, 9, 10, 11, 13 and 14)
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Completion of study questionaries by the subject.
6. Physical Examination by the principal investigator.
7. Investigational Product Administration:
- Drug Name: HB-adMSCs
- Route: Intravenous
- Dose: 200 million
- Vital signs monitoring 2 hours post drug exposure. (Every 15 minutes for the first
hour (0,15, 30, 45 and 60), and every 30 minutes for the second (90 and 120).
8. 24 hours telephone encounter after Investigational Product Administration to assess
incidence of adverse events or serious adverse events.
9. Adverse Events monitoring.
Visit 12 - Follow Up Visit.
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete
Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation
rate.
6. Completion of study questionaries by the subject.
7. Physical Examination by the principal investigator.
8. Adverse Events monitoring.
Visit 18. (End of Study)
1. Update Medical History Form if necessary.
2. Update Concomitant medications list if applicable.
3. Measurement of Weight in lb.
4. Collection of vital signs, including respiratory rate, pulse rate SPO2, blood pressure
and body temperature.
5. Collection of laboratory samples, including Comprehensive Metabolic Panel, Complete
Blood Count and Coagulation Panel, C - reactive protein and Erythrocyte sedimentation
rate.
6. Completion of study questionaries by the subject.
7. Physical Examination by the principal investigator.
8. Adverse Events monitoring.
