Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04029896 |
| Other study ID # |
HBCP01 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
October 2020 |
| 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 Protocol of Autologous HB-adMSCs for the
Treatment of Cerebral Palsy (CP) with the primary goal of treating 1 individual with CP who
has exhausted all treatment options, his condition has not improved, his quality of life is
severely affected by the condition and he has previously banked his mesenchymal stem cells.
There are no FDA approved, fully restorative treatments for CP. The subject will receive 8
autologous HB-adMSC infusions of 50 million (50 x 10^6 cells) total cells. A protocol
amendment to administer additional HB-adMSC infusions may be submitted for IRB/FDA for
approval depending on the patient's response, AE/SAEs, and cell expansion characteristics.
Description:
Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline
visit, the subject will return for the first infusions. Subsequent treatments will occur
every other week.
On each of these visits, the subject will receive one autologous HB-adMSC infusion of 50
million (50 x 10^6 cells) total cells. Every infusion visit will include the following
procedures:
1. Interval H&P update,
2. Weight
3. Vital signs monitoring (Heart Rate, BP, Resp., Temp., SpO2),
4. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel,
Serum Leptin),
5. A verification of patient/LAR consent will be verbally performed,
6. The HB-adMSC infusion will be given via IV over a 1 hour period.
7. The subject will then be monitored for a minimum of 4hr.
8. 24-hour telephone assessment for adverse events
9. Video Documentation
Follow Up Visits Week 4, 8, 12 and 16 (Safety Assessments)
The patient will be assessed for adverse events 24 hours after each infusion with a follow up
phone call. 4 weeks after the first infusion have occurred, the subject will return to the
clinical site for an onsite safety assessment, which will be repeated at week 8, 12, and 16.
Each one of these on-site safety assessments will include:
1. Review and update medical history,
2. Update concomitant medications list
3. Video documentation
4. Weight
5. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
6. Physical exam,
7. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel
and serum leptin)
8. SARAH assessment on Weeks 4, 12 and 16.
9. Adverse event monitoring Follow Up Visit Week 26 (Safety Assessments)
1. Review and update medical history, 2. Update concomitant medications list 3. Weight 4.
Vital signs (Heart Rate, BP, Respirations, Temp., SpO2), 5. Physical exam, 6. A urine and
blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel and serum leptin),
7. Brain MRI 8. The SARAH (motor-functional evaluation scale for children and adolescents
with cerebral palsy) 9. Adverse event monitoring 10. Video documentation
Follow Up Visit Week 52 (Safety Assessments-End of Study)
1. Review and update medical history,
2. Update concomitant medications list
3. Weight
4. Vital signs (Heart Rate, BP, Respirations, Temp., SpO2),
5. Physical exam,
6. A urine and blood sample for clinical labs (CBC with diff., CMP, and Coagulation Panel
and serum leptin),
7. Chest X ray (PA Single view)
8. The SARAH (motor-functional evaluation scale for children and adolescents with cerebral
palsy)
9. Adverse event monitoring
10. Video documentation
