Intermediate Size Patient Population Expanded Access IND for the Treatment of Patients With Parkinson's Disease.
- Conditions
- Parkinson Disease
- Registration Number
- NCT04772378
- Lead Sponsor
- Hope Biosciences Stem Cell Research Foundation
- Brief Summary
This Expanded Access IND is to evaluate the safety of multiple intravenous administrations of HB-adMSCs for treating Parkinson's disease in 10 patients between 76 and 95 y/o who do not qualify for other investigations.The dose to use for this expanded access is 200 million HB-adMSCs, administered through intravenous infusion only, with a treatment duration of 18 weeks. The program includes an up to 28 days screening period, an 18-week Treatment Period, and a 6-week Safety Follow-up Period.
- Detailed Description
This expanded access program is designed to include adult male and female outpatients with Parkinson's disease with ages between 76 and 95 y/o.
-Screening During the Screening Visit, each patient who participates in the expanded access program must sign an informed consent form that the IRB has approved before any related procedures can be performed.
In addition to completing the informed consent process, the designated personnel are responsible for conducting the evaluations listed in the Schedule of Assessments. These evaluations include the following:
* Collection of vital signs, demographic information, and concomitant medications.
* Evaluation of the eligibility requirements for participation in the expanded access program.
* Weight and height measurements.
* Lab sample collection. (Comprehensive Metabolic Panel, Complete Blood Count \& Coagulation Tests).
* Physical examination.
* Parkinson's disease assessments. (MDS-UPDRS, PDQ-39, PFS-16, PHQ-9, and VAS). Once these assessments have been performed and the results of laboratory tests have been obtained, the principal investigator must evaluate whether the screened patient is eligible to participate in the expanded access program. If a participant meets the eligibility requirements for participation in the expanded access program, infusion number 1 (the baseline visit) must be scheduled.
* Infusions Every patient who qualifies for participation in the expanded access program will be invited to receive autologous HB-adMSCs infusions. The administration of investigational products will take place at the Hope Biosciences Stem Cell Research Foundation, where the delegated personnel will closely monitor patients' vital signs.
Following the Sponsor Standard Operating Procedures, Hope Biosciences autologous adipose- derived mesenchymal stem cells should be mixed and administered to each eligible patient. HB-adMSCs should only be administered intravenously and a vital sign monitoring of two hours post-drug exposure. Monitoring intervals of 0, 15, 30, 45, 60, 90, and 120 minutes.
Additional to the administration of the investigational product, the delegated personnel should complete the following assessments.
* Collection of vital signs, as well as updates on medical history and concomitant medications if needed.
* Weight measurement.
* Collection of laboratory samples at INF 1 and INF 5. (Comprehensive Metabolic Panel, Complete Blood Count\& Coagulation Tests).
* Physical examination.
* Parkinson's disease assessments. (MDS-UPDRS, PDQ-39, PFS-16, PHQ-9, and VAS).
* Video documentation at INF 1 and INF 5 to evaluate the patient's gait, facial expression, and other symptoms associated with the disease.
* Determination of the incidence of AEs and SAEs. Immediately following the completion of each infusion, the patient should be assessed to ensure that the post-infusion discharge criteria have been met.
* Follow Up A follow-up will be conducted during this visit. Delegated personnel will communicate with the patient to determine whether any adverse events or serious adverse events have occurred since the last visit. Also, during this visit, updates on medical history and concomitant medications must be recorded in the patient's chart if needed.
* End of Expanded Access Program
Patients will be assessed by delegated personnel on the last visit of the expanded access program, which will take place at week 26. The following assessments will be performed:
* Collection of vital signs, as well as updates on medical history and concomitant medications if needed.
* Weight measurement.
* Collection of laboratory samples. (Comprehensive Metabolic Panel, Complete Blood Count\& Coagulation Tests).
* Physical examination.
* Parkinson's disease assessments. (MDS-UPDRS, PDQ-39, PFS-16, PHQ-9, and VAS).
* Video documentation to evaluate the patient's gait, facial expression, and other symptoms associated with the disease.
* Determination of the incidence of AEs and SAEs.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hope Biosciences Stem Cell Research Foundation
🇺🇸Sugar Land, Texas, United States