Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04064983 |
| Other study ID # |
HBPN01 |
| 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 Individual Patient Expanded Access IND has been created as requested by an 58-year-old
man who suffers from Polyneuropathy due to Polyneuropathy, Organomegaly, Endocrinopathy,
Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome. The patient will receive 8
infusions of 200 million cells every four weeks during a 28-week period to relieve the
symptoms of Polyneuropathy arising due to POEMS.
Description:
A screening visit will be conducted to assess the eligibility for this investigation. If the
participant qualifies the expanded access program eligibility requirements, he will be
treated with the investigational product in the following manner:
The patient will receive 8 infusions of 200 million cells every four weeks during a 28-week
period.
This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary
efficacy of autologous HB-adMSCs for treating a single patient with Polyneuropathy due to
POEMS Syndrome. The expanded access program will include a screening period of up to 28 days,
a 28-week treatment period, a safety follow-up, and a 52-week end-of-study visit.
An informed consent form will be given to the participant, who will sign before any
procedures.
The informed consent form will include information about this expanded access and all the
aspects considered during this process. The following are components of the informed consent
process that research personnel should adhere to:
- The principal investigator and team will make sure the participant is alert and able to
read and understand the language in the consent form.
- The principal investigator and team will ensure the participant takes ample time to read
the consent form carefully.
- The principal investigator and team will ensure the consent form is carefully explained
to the participant or legal guardian. Any questions or concerns should be addressed
before signing the document.
- Other aspects to consider, such as voluntary participation in the expanded access
program, will be followed according to FDA guidance, IRB Guidelines for Researchers and
Sponsor standard operating procedure
The participant is required to complete the subsequent visits after they have given their
informed consent.
- Visit 1 - Screening during this period, the principal investigator will determine
whether the screened participant is eligible and whether the next visit can be
scheduled. Once the principal investigator has evaluated the eligibility (up to 28
days), the patient will be scheduled for the first infusion.
- Visit 2 - Infusion 1 (Baseline): this visit will be a starting point for comparing
participants' data. During this visit, the patient will receive the 1st investigational
product via intravenous infusion, with rigorous monitoring of vital signs for a total of
2 hours.
- Visit 3 to 9 - During these visits, the patient will receive intravenous infusions of
HB-adMSCs while her vital signs are precisely monitored for a total of 2 hours.
- Follow-Up Visit - During this safety follow-up visit, the principal investigator will
evaluate the safety of the investigational product by conducting several assessments
described in the Schedule of Assessments table.
- End of Study - At the end of the expanded access program visit, the principal
investigator will conduct various evaluations to determine the patient's physical
condition and assess whether there have been any safety events resulting from the
participation in the expanded access program.
