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

September 24, 2025 updated by: Hope Biosciences Research Foundation

An Expanded Access IND to Evaluate the Safety and Preliminary Efficacy of Autologous HB-adMSCs for the Treatment of a Single Patient With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

This is an Individual Patient Expanded Access IND to evaluate the safety and preliminary efficacy of autologous HB-adMSCs for treating a single patient Chronic Inflammatory Demyelinating Polyneuropathy, CIDP. The expanded access program will include a screening period of up to 28 days, a 44-week treatment period, a safety follow-up at 50, and a 52-week end-of-study visit.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Sugar Land, Texas, United States, 77478
        • Hope Biosciences Stem Cell Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hope Biosciences Research Foundation

Collaborators

Hope Biosciences

Investigators

  • Principal Investigator: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBCIDP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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