Phase 2
N=24
Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05116540 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
May 2025
Primary outcome: Primary: Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument — 53.85; 44.07; 8.21; 7.03 score on a scale (100 points total)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HB-adMSCs (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hope Biosciences Research Foundation
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument |
53.85; 44.07; 8.21; 7.03; 6.68; 3.43 | — |
| PRIMARY Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
65.37; 60.88; 11.04; 6.39; 8.81; 3.22 | — |
| PRIMARY Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
59.55; 64.50; 10.45; 6.50; 5.91; 5.50 | — |
| PRIMARY Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
71.27; 68.40; 6.91; 3.60; 6.55; 3.20 | — |
| PRIMARY Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
54.09; 36.00; 19.55; 16.50; 13.18; 4.50 | — |
| PRIMARY Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
63.64; 73.33; 15.15; 3.33; 15.15; 0.00 | — |
| PRIMARY Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
71.82; 48.50; 6.05; 7.00; 3.04; 4.67 | — |
| PRIMARY Change From Baseline in Energy/Fatigue Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
48.00; 32.00; 6.18; 13.60; 4.36; 10.40 | — |
| PRIMARY Change From Baseline in Health Perception Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
59.55; 42.00; 9.09; 5.00; 0.00; 3.50 | — |
| PRIMARY Change From Baseline in Physical Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
36.36; 43.00; 1.36; -1.50; 12.27; -6.00 | — |
| PRIMARY Change From Baseline in RL/Physical Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
38.64; 20.00; 11.36; 22.50; 6.82; 17.50 | — |
| PRIMARY Change From Baseline in Pain Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
71.82; 59.83; 7.12; 7.17; 4.55; 4.34 | — |
| PRIMARY Change From Baseline in Social Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
67.42; 59.17; 6.06; -2.50; 5.30; -1.67 | — |
| PRIMARY Change From Baseline in Sexual Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument. |
65.15; 71.67; 8.33; -2.50; 8.34; -3.33 | — |
| PRIMARY Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 |
19.872; -2.248 | 0.0002 sig |
| PRIMARY Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 Composite Score |
13.362; -2.402 | 0.0166 sig |
| PRIMARY Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Physical Health Composite Score Change From Baseline Multiple Sclerosis Quality of Life (MSQOL)-54 |
18.373; -3.764 | 0.9905 |
| PRIMARY Bayesian Statistical Analysis - Analysis of Covariance (ANCOVA) Model - Mental Health Composite Score Change From Baseline - Multiple Sclerosis Quality of Life (MSQOL)-54 |
12.414; -3.333 | 0.8292 |
| SECONDARY Analysis of Covariance (ANCOVA) Model - Total Expanded Disability Status Scale (EDSS) Scores Through Week 52 - Change From Baseline - Efficacy Analysis Set |
-1.502; 0.052 | 0.0278 sig |
| SECONDARY Analysis of Covariance (ANCOVA) Model - Change From Baseline Barthel Index Scores Through Week 52 - Efficacy Analysis Set |
2.359; -3.094 | 0.0666 |
| SECONDARY ANCOVA Model - Change From Baseline 9-Hole Peg Test Scores - Dominant Hand Avg Time Through Week 52 |
0.472; -9.639 | 0.0863 |
| SECONDARY Analysis of Covariance (ANCOVA) Model - Change From Baseline 9-Hole Peg Test Scores - Non-Dominant Hand Avg Time Through Week 52 |
-3.771; -4.747 | 0.5588 |
| SECONDARY Analysis of Covariance (ANCOVA) Model - Change in Patient Health Questionnaire (PHQ-9) Test Scores |
-4.330; 0.263 | 0.0004 sig |
| SECONDARY Baseline Vitals Values - Height |
166.17; 167.86 | — |
| SECONDARY Change From Baseline Vitals Values - Weight |
68.61; 76.55; 0.15; 0.18; -0.04; -0.05 | — |
| SECONDARY Change From Baseline Vitals Values - Body Mass Index |
24.72; 27.17; 0.05; 0.07; -0.00; -0.04 | — |
| SECONDARY Change From Baseline Vitals Values - Respiratory Rate |
16.7; 16.3; 0.0; 0.2; 0.0; 0.4 | — |
| SECONDARY Change From Baseline Vitals Values - Temperature |
36.66; 36.84; -0.01; -0.23; 0.03; -0.21 | — |
| SECONDARY Change From Baseline Vitals Values - Systolic Blood Pressure |
119.2; 122.2; 6.3; 0.8; -5.0; -2.8 | — |
| SECONDARY Change From Baseline Vitals Values - Diastolic Blood Pressure |
76.3; 78.9; 2.5; 1.1; -1.3; 0.0 | — |
| SECONDARY Change From Baseline Vitals Values - Pulse Rate |
71.8; 76.2; 0.4; -0.9; 3.3; 2.4 | — |
| SECONDARY Change From Baseline Vitals Values - Oxygen Saturation |
98.4; 98.0; -0.7; 0.6; -0.4; 0.5 | — |
| SECONDARY Change From Baseline Physical Examination Results - Abdomen |
12; 12; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Cardiovascular |
12; 12; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - HEENT |
12; 12; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Lymph Node |
12; 12; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Musculoskeletal |
6; 3; 6; 9; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Neurological |
2; 1; 10; 11; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Respiratory |
12; 12; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline Physical Examination Results - Skin |
11; 12; 1; 0; 0; 0 | — |
| SECONDARY Laboratory Values - CBC (x10^3 Cells/uL) |
0.027; 0.030; 0.008; 0.003; 0.008; -0.001 | — |
| SECONDARY Laboratory Values - CBC (% of WBC) |
0.40; 0.74; 0.22; 0.09; 0.03; -0.13 | — |
| SECONDARY Laboratory Values - CBC (% of Total Blood Cell Count) |
39.80; 40.77; -0.48; 1.43; 1.02; 2.51 | — |
| SECONDARY Laboratory Values - CBC (g/dL) |
13.60; 13.68; -0.18; 0.61; 0.21; 0.81 | — |
| SECONDARY Laboratory Values - CBC (pg) |
31.20; 30.38; -0.23; 0.50; -0.25; 0.44 | — |
| SECONDARY Laboratory Values - CBC (fL) |
91.36; 90.59; -0.60; 0.65; 0.15; 1.32 | — |
| SECONDARY Laboratory Values - CBC (x10^6 Cells/uL) |
4.362; 4.507; -0.027; 0.134; 0.100; 0.222 | — |
| SECONDARY Laboratory Values - CBC (RDW) |
12.51; 12.82; 0.21; 0.57; 0.07; 0.35 | — |
| SECONDARY Laboratory Values - CMP (g/dL) |
4.70; 4.64; -0.03; -0.03; 0.00; -0.03 | — |
| SECONDARY Laboratory Values - CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL)) |
1.89; 2.23; 0.10; 0.08; 0.11; 0.04 | — |
| SECONDARY Laboratory Values - CMP (U/L) |
77.5; 69.0; -2.6; -0.3; 5.5; 1.0 | — |
| SECONDARY Laboratory Values - CMP (mg/dL) |
0.41; 0.44; 0.01; 0.15; -0.02; 0.09 | — |
| SECONDARY Laboratory Values - CMP (mEq/L) |
103.5; 103.7; -0.3; 1.4; 0.2; 0.8 | — |
| SECONDARY Laboratory Values - CMP (mL/Min/1.73m^2) |
99.5; 94.4; -1.7; 0.2; -0.8; -2.7 | — |
| SECONDARY Laboratory Values - CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)) |
19.7; 16.3; -0.6; 0.4; 2.5; -0.6 | — |
| SECONDARY Laboratory Values - Coagulation Panel (Seconds) |
12.95; 13.23; 1.00; 0.08; 1.28; 0.12 | — |
| SECONDARY Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds)) |
0.94; 0.96; 0.11; 0.04; 0.14; 0.02 | — |
Summary
Randomized Double-Blind Efficacy and safety study of Autologous HB-adMSCs versus placebo for the treatment of Multiple Sclerosis. This study will be for 24 subjects with 6 infusions over a 52 week period. Study participants will continue their established concomitant medications during participation in this investigation.
Eligibility Criteria
Inclusion Criteria
- Male and female participants 18 - 75 years of age.
- Study participants must have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation.
- Study participants must be stabilized on any MS therapy for at least 6 months prior to randomization.
- Study participants must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial.
- Study participants must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk).
- Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences.
- Study participants should be able to read, understand, and provide written consent.
- Before any clinical-trial-related procedures are performed, informed consent must be obtained from the participants voluntarily.
- Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. *
- Male participants, if their sexual partners can become pregnant, should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. *
- Study participant is able and willing to comply with the requirements of this clinical trial.
- Participants in the study should have evidence of disease, as shown by MRIs of the brain or spinal cord, with the most recent being within 1 year of the screening date, and no other signs of relapse.
Exclusion Criteria
- Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. *
- Study participants with other types of multiple sclerosis, such as progressive relapsing, primary or secondary progressive.
- Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
- Study participant has known addiction or dependency or has current substance use or abuse.
- Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
- Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose >130mg/dl during screening visit or post-prandial glucose >200mg/dl.
- Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR 180/120 mm/Hg during screening visit.Medical history of diseases such as, inherited thrombophilias, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach).
- Medical history of conditions, such as recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips, or femur.
- Study participant has received any stem cell treatment within 12 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
- The study participant has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
- Study participant has a laboratory abnormality during screening, including the following:
- White blood cell count < 3000/mm3
- Platelet count < 80,000mm3
- Absolute neutrophil count < 1500/mm3
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5
- Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator poses a safety risk or will prevent the subject from completing the study.
- The study participant has any concurrent neurologic disease, including hereditary conditions that the principal investigator considers could interfere with the study participation. Some of these neurologic
Data sourced from ClinicalTrials.gov (NCT05116540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.