Chronic Inflammatory Demyelinating PolyneuropathyNCT04825626
An Expanded Access IND for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
A study testing HB-adMSCs in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Hope Biosciences Research Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- HB-adMSCs
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records.
- Patient must have banked his stem cells at Hope Biosciences LLC.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Stem Cell Research Foundation
Sugar Land, Texas, 77478
About this study
Official title: 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.
Read the 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.
- Being tested
- HB-adMSCs
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCsBiological
Also called MSCs
Hope Biosciences adipose derived Mesenchymal Stem Cells.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Djamchid Lotfi, MD, Principal investigator, Hope Biosciences Stem Cell Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825626
- Sponsor's protocol ID
- HBCIDP01
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2021
- Last updated
- 29 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04825626
- Acronym / sponsor ID
- HBCIDP01
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-adMSCsAlso: MSCsHope Biosciences adipose derived Mesenchymal Stem Cells. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamchid Lotfi, MD principal investigator
Hope Biosciences Stem Cell Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB-adMSCs in people with Chronic Inflammatory Demyelinating Polyneuropathy, run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.