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

NCT04825626 | Unknown

• 1 other identifier: HBCIDP01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

HB-adMSCs BIOLOGICAL

Hope Biosciences adipose derived Mesenchymal Stem Cells.

Also known as: MSCs

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, with documented medical records.
• Patient must have banked his stem cells at Hope Biosciences LLC.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)