CompletedPhase 2

Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis

United States24 participantsStarted 2021-11-24

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument

Timeframe: Baseline to Week 52

Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Trial details

NCT IDNCT05116540

SponsorHope Biosciences Research Foundation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-04

Results submitted2024-12-20

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Change From Baseline in Physical Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument

Timeframe: Baseline to Week 52

Change From Baseline in Mental Health Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Cognitive Function Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Emotional Well-Being Composite Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Health Distress Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in RL/Emotional Problems Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52

Change From Baseline in Overall Quality of Life Score - Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Timeframe: Baseline to Week 52