This protocol is part of a clinical study to evaluate efficacy and safety of multiple intravenous administrations of HB-adMSCs for the treatment of Multiple Sclerosis.
This clinical trial is designed as an open label, single center, phase 2 study to assess the efficacy and safety of multiple autologous adipose derived mesenchymal stem cells in patients with Relapsing Remitting Multiple Sclerosis. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be opened to enroll up to 10 eligible subjects diagnosed with Relapsing Remitting Multiple Sclerosis. Each eligible study subject will receive a total of 6 intravenous infusions of HB-adMSCs. Study infusions will be administered with the following regimen, Week 0, 4, 8, 16, 24 and 32, this dosing interval has been selected because due to the efficacy observed in the completed placebo-controlled counterpart to this study, HBMS01 (IND 027633, NCT05116540). Efficacy was observed at the end of study visit (week 52), post-therapy with six infusions of HB-adMSCs. The following objectives will be investigated: efficacy as determined by the Multiple Sclerosis Quality of Life (MSQOL-54) Instrument, efficacy as determined by changes in Expanded Disability Status Scale (EDSS), safety as determined by changes in Patient Health Questionnaire (PHQ-9), and safety as determined by the incidence of adverse events or serious adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous HB-adMSCs
Hope Biosciences Research Foundation
Sugar Land, Texas, United States
Change from Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument scores
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Time frame: 1 year
Change from Baseline in Expanded Disability Status Scale (EDSS) scores
The EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. This scale ranges from 0 to 10 in 0.5-unit increments and a higher score represents increased disability. Scoring is based on an examination by a neurologist.
Time frame: 1 year
Change from Baseline in Patient Health Questionnaire (PHQ-9) scores
The PHQ-9 is the most used depression and suicidal thoughts screening test used to monitor the severity of depression and response to treatment. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time frame: 1 year
Incidence of treatment-emergent Adverse Event (TEAEs)
The number of patients and count of TEAEs of all patients in the study
Time frame: 1 year
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Incidence of serious Adverse Events (SAEs)
Incidence of serious Adverse Events (SAEs)
Time frame: 1 year
Incidence of AEs of special interest (serious or nonserious)
Incidence of AEs of special interest (serious or nonserious), including thromboembolic events, peripheral events defined as, thromboembolism of the extremities, also infections and hypersensitivities.
Time frame: 1 year
Clinically significant changes in laboratory value results
Clinically significant changes in laboratory values results (laboratory values assessed will be separated into different outcomes by respective unit)
Time frame: 1 year
Clinically significant changes in vital signs
Clinically significant changes in vital signs (vital signs assessed will be separated into different outcomes by respective unit)
Time frame: 1 year
Clinically significant changes in weight
Clinically significant changes in weight (measured in pounds)
Time frame: 1 year
Clinically significant changes in physical examination results
Clinically significant changes in physical examination results
Time frame: 1 year
Clinically significant changes in Multiple Sclerosis concomitant medications
Clinically significant changes in Multiple Sclerosis concomitant medications
Time frame: 1 year