Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04825613 |
| Other study ID # |
HBPLS01 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
June 2023 |
| Source |
Hope Biosciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial Summary
This Individual Patient Expanded Access IND has been created as requested by an 83-year-old
man who suffers Primary Lateral Sclerosis and for which the drugs currently approved are not
providing an improvement over the progression of this disease.
Description:
-Screening This expanded access IND was created at the request of the subject who already has
his own stem cells banked at Hope Biosciences, LLC. After receiving authorization from FDA
and Western IRB, the subject will be contacted and provided with a copy of the informed
consent for review. The Principal Investigator or delegated staff will meet with the patient
in person or by telephone and explain the study procedures (including cell infusion, 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 make a decision about
participation. If consent is obtained, the principal investigator or delegated staff will
collect patient's medical history and schedule the date for the Infusion 1. The informed
consent process will be documented in the subject's record and will include the discussion
points mentioned above. A copy of the signed informed consent will be placed in the record.
-HB-adMSCs Administrations. Subject will receive a total of twelve autologous HB-adMSCs
infusion of 200 million cells with a dosing interval of 28 days over a 44-week period during
the first and second year of treatment. Laboratory assessments will be collected at different
visits across the study.
Other assessments should be completed during these visits by the Investigator and/or
delegated staff to evaluate the safety and efficacy of HB-adMSCs,
1. Collection of Medical History
2. Collection of Concomitant Medications.
3. Collection of Vital Signs (Respiratory Rate, Blood Pressure, Body Temperature, Heart
Rate and Oxygen Saturation). Vital Signs will be collected for 2 hours post
investigational product exposure. Every 15 minutes for the first hour and every 30
minutes after that. If it is indicated by principal investigator vital signs should be
collected more frequently.
4. Collection of Weight and Height (Height measurement is only necessary at infusion 1)
5. EMG NCV is required to be completed at Infusion 1 and 7. If an EMG NCV has not been done
within 28 days of these visit, the Principal Investigator will place an order to obtain
it. Any EMG NCV done within 28 days of the visit as standard of care can be used for
this requirement.
6. Physical Examination.
7. ALS Functional Rating Scale-Revised (ALSFRS-R) at Infusion 1 and 7.
8. Neuro QOL Scale at Infusion 1 and 7.
9. A video documentation of the subject will be recorded during Infusion 1 and 7 with the
purpose of observing his usual forms of communication and movements.
10. Laboratory Samples. A blood sample for clinical labs - CBC with Platelets, CMP, PT, PTT,
INR, as well as C-reactive protein, Sedimentation Rate and Vitamin B12 (Cobalamin) to be
collected at Infusion 1 and 7.
11. Telephone Encounter 24 hours after each infusion to evaluate the incidence of any
Adverse event or Serious Adverse Events.
- Follow Up 1 Week 48. (Phone call)
1. Update medical history and concomitant medications if there is any new information.
2. Assess the incidence of any Adverse event or Serious Adverse Events since last infusion.
- Infusions 13 through 24.
1. Collection of Medical History
2. Collection of Concomitant Medications.
3. Collection of Vital Signs (Respiratory Rate, Blood Pressure, Body Temperature,
Heart Rate and Oxygen Saturation). Vital Signs will be collected for 2 hours post
investigational product exposure. Every 15 minutes for the first hour and every 30
minutes after that. If it is indicated by principal investigator vital signs should
be collected more frequently.
4. Collection of Weight and Height (Height measurement is only necessary at infusion
1)
5. EMG NCV is required to be completed at Infusion 13 and 19. If an EMG NCV has not
been done within 28 days of these visit, the Investigator will place an order to
obtain it.
Any EMG NCV done within 28 days of the visit as standard of care can be used for
this requirement.
6. Physical Examination.
7. ALS Functional Rating Scale-Revised (ALSFRS-R) at Infusion 13 and 19.
8. Neuro QOL Scale at Infusion 13 and 19.
9. A video documentation of the subject will be recorded during Infusion 13 and 19
with the purpose of observing his usual forms of communication and movements.
10. Laboratory Samples. A blood sample for clinical labs - CBC with Platelets, CMP, PT,
PTT, INR, as well as C-reactive protein, Sedimentation Rate and Vitamin B12
(Cobalamin) to be collected at Infusion 13 and 19.
11. Telephone Encounter 24 hours after each infusion to evaluate the incidence of any
Adverse event or Serious Adverse Events.
- End of Study (Week 52)
1. Update medical history and concomitant medications if there is any new information.
2. Assess the incidence of any Adverse Event or Serious Adverse Events since last
visit.
3. Collection of Weight.
4. Collection of Vital Signs (Respiratory Rate, Blood Pressure, Body Temperature,
Heart Rate and Oxygen Saturation).
5. Laboratory Samples. A blood sample for clinical labs - CBC with Platelets, CMP, PT,
PTT, INR, as well as C-reactive protein, Sedimentation Rate and Vitamin B12
(Cobalamin).
6. Physical Examination.
7. ALS Functional Rating Scale-Revised (ALSFRS-R).
8. Neuro QOL Scale.
9. A video documentation of the subject will be recorded during this visit with the
purpose of observing his usual forms of communication and movements.
10. EMG NCV is required to be completed at EOS visit. If an EMG NCV has not been done
within 28 days of this visit, the Principal Investigator will place an order to
obtain it. Any EMG NCV done within 28 days of the visit as standard of care can be
used for this requirement.
