Individual Patient Expanded Access IND to Treat Polyneuropathy


Study First Submitted Date 2019-08-19
Study First Posted Date 2019-08-22
Last Update Posted Date 2022-07-28
Verification Month Year July 2022
Verification Date 2022-07-31
Last Update Posted Date 2022-07-28

Detailed Descriptions

Sequence: 20836886
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.


Sequence: 201166892
Name Hope Biosciences Stem Cell Research Foundation
City Sugar Land
State Texas
Zip 77478
Country United States


Sequence: 52466671
Name Polyneuropathies
Downcase Name polyneuropathies

Id Information

Sequence: 40370453
Id Source org_study_id
Id Value HBPN01


Sequence: 42805632
Name United States
Removed False


Sequence: 52776950
Intervention Type Biological
Name HB-adMSCs
Description Hope Biosciences autologous adipose-derived mesenchymal stem cells


Sequence: 80269947 Sequence: 80269948 Sequence: 80269949 Sequence: 80269950 Sequence: 80269951
Name Polyneuoropathy Name POEMS Name Pain Name Stem cells Name Neuropathic Pain
Downcase Name polyneuoropathy Downcase Name poems Downcase Name pain Downcase Name stem cells Downcase Name neuropathic pain

Browse Conditions

Sequence: 194615682 Sequence: 194615683 Sequence: 194615684 Sequence: 194615685
Mesh Term Polyneuropathies Mesh Term Peripheral Nervous System Diseases Mesh Term Neuromuscular Diseases Mesh Term Nervous System Diseases
Downcase Mesh Term polyneuropathies Downcase Mesh Term peripheral nervous system diseases Downcase Mesh Term neuromuscular diseases Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48593847
Agency Class OTHER
Lead Or Collaborator lead
Name Hope Biosciences Stem Cell Research Foundation

Overall Officials

Sequence: 29440218
Role Principal Investigator
Name Thanh Cheng, MD
Affiliation Hope Biosciences Stem Cell Research Foundation


Sequence: 30934871
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria

Patient diagnosed with Polyneuropathy due to POEMS Syndrome.
Patient must have banked his stem cells at Hope Biosciences LLC.

Exclusion Criteria

The patient has any active infection requiring medications.
The patient has any suicidal ideation during the screening visit.

Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254222130
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True

Responsible Parties

Sequence: 29047222
Responsible Party Type Sponsor