- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064983
Individual Patient Expanded Access IND to Treat Polyneuropathy
An Expanded Access IND to Evaluate the Safety and Efficacy of Autologous HB-adMSCs for the Treatment of a Single Patient With Polyneuropathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Locations
-
-
Texas
-
Sugar Land, Texas, United States, 77478
- Hope Biosciences Stem Cell Research Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBPN01
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.
Clinical Trials on Polyneuropathies
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Hospital Ambroise Paré ParisCompletedPostherpetic Neuralgia | Diabetic Polyneuropathies | Other PolyneuropathiesFrance, Brazil
-
Rigshospitalet, DenmarkDanish Cancer SocietyRecruiting
-
National Institute of Neurological Disorders and...Completed
-
NovaMed Pharmaceuticals Inc.Unknown
-
University Medical Center GroningenCompleted
-
Centre Hospitalier Intercommunal de Toulon La Seyne...CompletedTechnique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies (FIBREC)Peripheral Nervous System DiseasesFrance
-
German Cancer Research CenterUniversity Hospital Heidelberg; National Center for Tumor Diseases, HeidelbergCompletedExercise | Chemotherapy-induced PolyneuropathyGermany
-
M.D. Anderson Cancer CenterWithdrawnPolyneuropathies and Other Disorders of the Peripheral Nervous System | Chemotherapy Induced Neuropathic Pain
Clinical Trials on HB-adMSCs
-
Hope BiosciencesThe University of Texas Health Science Center, HoustonActive, not recruiting
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer availableParkinson DiseaseUnited States
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer availablePost COVID-19 SyndromeUnited States
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer availableAmyotrophic Lateral SclerosisUnited States
-
Hope BiosciencesThe University of Texas Health Science Center, HoustonNo longer availableSpinal Cord Injury at C5-C7 LevelUnited States
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer availableCongenital Muscular Dystrophy Due to Lamin A/C MutationUnited States
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesCompleted
-
Hope BiosciencesCompletedRheumatoid ArthritisUnited States
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesWithdrawn
-
Hope Biosciences Stem Cell Research FoundationHope BiosciencesNo longer available