An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)


Study First Submitted Date 2021-03-25
Study First Posted Date 2021-04-01
Last Update Posted Date 2022-09-22
Verification Month Year September 2022
Verification Date 2022-09-30
Last Update Posted Date 2022-09-22

Detailed Descriptions

Sequence: 20559363
Description 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 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 participant's 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 12 – 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 Phone Call – During this safety follow-up phone call, 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: 198498697
Name Hope Biosciences Stem Cell Research Foundation
City Sugar Land
State Texas
Zip 77478
Country United States


Sequence: 51754337
Name Chronic Inflammatory Demyelinating Polyneuropathy
Downcase Name chronic inflammatory demyelinating polyneuropathy

Id Information

Sequence: 39825544
Id Source org_study_id
Id Value HBCIDP01


Sequence: 42225620
Name United States
Removed False


Sequence: 52075719
Intervention Type Biological
Name HB-adMSCs
Description Hope Biosciences adipose derived Mesenchymal Stem Cells.

Browse Conditions

Sequence: 191805843 Sequence: 191805844 Sequence: 191805845 Sequence: 191805846 Sequence: 191805847 Sequence: 191805848 Sequence: 191805849 Sequence: 191805850 Sequence: 191805851 Sequence: 191805852 Sequence: 191805840 Sequence: 191805841 Sequence: 191805842
Mesh Term Neuromuscular Diseases Mesh Term Nervous System Diseases Mesh Term Polyradiculoneuropathy Mesh Term Autoimmune Diseases of the Nervous System Mesh Term Demyelinating Diseases Mesh Term Autoimmune Diseases Mesh Term Immune System Diseases Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes Mesh Term Polyneuropathies Mesh Term Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Mesh Term Peripheral Nervous System Diseases
Downcase Mesh Term neuromuscular diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term polyradiculoneuropathy Downcase Mesh Term autoimmune diseases of the nervous system Downcase Mesh Term demyelinating diseases Downcase Mesh Term autoimmune diseases Downcase Mesh Term immune system diseases Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes Downcase Mesh Term polyneuropathies Downcase Mesh Term polyradiculoneuropathy, chronic inflammatory demyelinating Downcase Mesh Term peripheral nervous system diseases
Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor


Sequence: 47931653 Sequence: 47931654
Agency Class OTHER Agency Class INDUSTRY
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Hope Biosciences Stem Cell Research Foundation Name Hope Biosciences

Overall Officials

Sequence: 29041316
Role Principal Investigator
Name Djamchid Lotfi, MD
Affiliation Hope Biosciences Stem Cell Research Foundation


Sequence: 30521665
Gender All
Minimum Age N/A
Maximum Age N/A
Criteria Inclusion Criteria Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records. 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 or at any point during the study.
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254082090
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True

Intervention Other Names

Sequence: 26471256
Intervention Id 52075719
Name MSCs

Responsible Parties

Sequence: 28650823
Responsible Party Type Sponsor