Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04064957 |
| Other study ID # |
HBSCI02, HBSCI04, HBSCI05 |
| 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
HBSCI02:
This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request
submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about
4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was
immediately unable to move his legs. He discharged to Texas via air ambulance for physical
rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury
Association) C-5 SCI (spinal cord injury).
HBSCI04:
This Individual Patient Expanded Access IND has been created per the request of a 75-year-old
man who has been diagnosed with Spinal Cord Injury. The patient requested this Expanded
Access IND with the purpose of possible restoration of nerve transmission and restoring
sensation in his upper and lower body using intravenous autologous adipose derived
mesenchymal stem cells.
HBSCI05:
This Individual Patient Expanded Access IND has been created per the request of a 26-year-old
man who has been diagnosed with Spinal Cord Injury. The patient is a 26-year-old male who
suffered an unstable C-6 compressive fracture, crushing the vertebral body and retropulsion
of a large bone fragment into the vertebral canal, stenosing 75% of spinal canal in a diving
accident on 12/4/2021 in Belize City, Belize. The injury classification is C-6 Asia A injury.
The injury left him with flaccid paralysis below the level of C-7 dermatome.
Description:
HBSCI02:
Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline
visit, the subject will receive the first infusion. Subsequent treatments will occur every
other week in the subject's home, administered by a nurse.
On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200
million (2 x 10^8 cells) total cells. Every infusion visit will include the following
procedures:
1. Interval H&P and concomitant medications update.
2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the
assistance of the primary caregiver.
3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2).
4. A peripheral IV line will be inserted.
5. A blood sample for clinical labs will be drawn monthly during the infusion period.
6. A "time out" verification of patient/consent/procedure/cell product will be performed.
7. The HB-adMSC infusion will be given by through the peripheral IV.
8. Assessment for Infusion Related AE/SAEs.
9. The subject will be monitored for a minimum of 2 hours.
In-Person Visits The subject will return to the Clinical Trial Network CTN site for In-Person
visits to occur at Screening, Baseline and Week twelve (12), twenty-six (26) and at Week
fifty-two (52). Week 52 visit will serve as the End of Study visit. The end of study (EOS)
visit will include an MRI of the c-spine as well as all of the study procedures for Follow-up
Visits without Infusion. A written summary of the results of the treatment, including adverse
events will be submitted to the FDA after completion of the last follow-up visit.
Visits without infusion will include:
1. Interval H&P and concomitant medications update.
2. QOL and Disability (SCIM self eval) surveys will be completed by the subject with the
assistance of the primary caregiver.
3. Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2),
4. A Physical and Neuro Exam (Asia Impairment Scale) will be completed
5. A blood sample for clinical labs (CBC with Platelets, CMP, PT, PTT, TNFa, IL6, CRP) will
be drawn.
6. Video documentation of patient condition.
7. Assessment for infusion related AEs/SAEs
8. Weight
HBSCI04:
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. 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 given to the
patient and also placed in the record.
Subject will receive a total of fourteen autologous HB-adMSCs infusion of 200 million cells
with a dosing interval of approximately 2 weeks for the first five infusions and 28 days for
the remaining 9 infusions over a 44-week period, Laboratory assessments will be collected at
Infusion 1, 10, and EOS.
Other assessments should be completed during these visits by the Principal Investigator
and/or delegated staff in order 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. EMG NCV is required to be completed at Infusion 1 and EOS. If an EMG NCV has not been
done within 28 days of these visits, 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.
5. A Physical and Neuro Examination will be completed by the principal investigator.
6. Neuro QOL Scale at Infusion 1, 5, 7, 9, 11 and 13.
7. SCIM (Spinal Cord Independence Measure) Clinician assessment at Infusion 1, 10 and EOS.
8. SCIM (Self-Assessment) at Infusion 1, 10, and EOS.
9. A video documentation of the subject will be recorded during Infusion 1 with the purpose
of observing his general physical health, trunk stability and if there are other new
changes.
10. Laboratory Samples. A blood sample for clinical labs - CBC with Platelets, CMP, PT, PTT,
INR, as well as C-reactive protein and Sedimentation rate to be collected at Infusion 1
and 10 and EOS.
11. Telephone Encounter 24 hours after each infusion to evaluate the incidence of any
Adverse event or Serious Adverse Events.
Follow Up 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.
End of Study End of Study will include the following study procedures,
1. Interval H&P and concomitant medications update.
2. Neuro QOL and Disability (SCIM self eval) surveys will be completed by the subject.
3. EMG NCV is required to be completed at this 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.
4. Vital signs monitoring will be initiated (Heart Rate, Blood Pressure, Resp., Temp.,
SpO2)
5. A Physical and Neuro Examination will be completed by the principal investigator.
6. A blood sample for clinical labs will be collected CBC with Platelets, CMP, PT, PTT,
INR, as well as C-reactive protein and Sedimentation rate.
7. A video documentation of the subject will be recorded during this visit with the purpose
of observing his general physical health and if there are other new changes.
8. Assess the incidence of any Adverse event or Serious Adverse Events since last infusion.
HBSCI05:
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 contact the patient 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 given to the
patient and also placed in the record.
Subject will receive a total of fourteen autologous HB-adMSCs infusion of 200 million cells
with a dosing interval of approximately 2 weeks for the first five infusions and 28 days for
the remaining 9 infusions over a 44-week period, volume to administer 250 ml of Sodium
Chloride 0.9% and infusion rate 4 - 5 ml/min. Laboratory assessments will be collected at
Infusion 1, 10, and EOS.
Other assessments should be completed during these visits by the Principal Investigator
and/or delegated staff in order 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 taken for 1 hour during exposure to the
research product with an interval of 15 minutes. However, if warranted or indicated by
the investigator vital signs will be taken more frequently or longer if necessary.
4. EMG NCV is required to be completed at Infusion 1 and EOS. If an EMG NCV has not been
done within 28 days of these visits, 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.
5. A Physical and Neuro Examination will be completed by the principal investigator.
6. Neuro QOL Scale at Infusion 1, 5, 7, 10, 11 and 13, and EOS.
7. SCIM (Spinal Cord Independence Measure) Clinician assessment at Infusion 1, 10 and EOS.
8. SCIM (Self-Assessment) at Infusion 1, 10, and EOS.
9. A video documentation of the subject will be recorded during Infusion 1 with the purpose
of observing his general physical health, trunk stability and if there are other new
changes.
10. Laboratory Samples. A blood sample for clinical labs - CBC with Platelets, CMP, PT, PTT,
INR, as well as C-reactive protein and Sedimentation rate to be collected at Infusion 1
and 10 and EOS.
11. Telephone Encounter 24 hours after each infusion to evaluate the incidence of any
Adverse event or Serious Adverse Events.
Follow Up 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.
End of Study
End of Study will include the following study procedures,
1. Interval H&P and concomitant medications update.
2. Neuro QOL and Disability (SCIM self eval) surveys will be completed by the subject.
3. EMG NCV is required to be completed at this 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.
4. Vital signs monitoring will be initiated (Heart Rate, Blood Pressure, Resp., Temp.,
SpO2)
5. A Physical and Neuro Examination will be completed by the principal investigator.
6. A blood sample for clinical labs will be collected CBC with Platelets, CMP, PT, PTT,
INR, as well as C-reactive protein and Sedimentation rate.
7. A video documentation of the subject will be recorded during this visit with the purpose
of observing his general physical health and if there are other new changes.
8. Assess the incidence of any Adverse event or Serious Adverse Events since last infusion.
