Active — Not RecruitingPhase 2

"HB-adMSCs for the Treatment of Patients With Multiple Sclerosis"

United States10 participantsStarted 2025-05-02

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Male and female subjects 18 - 75 years of age.
✓. Study subjects must have been diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation.
✓. Study subjects must have been randomized into the placebo group and completed participation in the HBMS01 clinical trial (IND 027633). (A randomized, double-blind, single center, phase 2 clinical trial that assessed the efficacy and safety of autologous HB-adMSCs vs placebo for the treatment of patients with Multiple Sclerosis.)
✓. Study subjects must be stabilized on any MS therapy for at least 6 months prior to enrollment.
✓. Study subjects must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial.
✓. Study subjects must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk).
✓. Study subjects must have previously banked their mesenchymal stem cells with Hope Biosciences.
✓. Study subjects should be able to read, understand and to provide written consent.

Exclusion criteria

✕. Women who are currently pregnant or lactating.
✕. Study subject has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
✕. Study subject has known addiction or dependency or has current substance use or abuse.
✕. Study subject has 1 or more significant concurrent medical conditions (verified by medical records), including the following:
✕. Study subject 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 subject has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
✕. Study subject has a laboratory abnormality during screening, including the following:
✕. Study subject 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.

What they're measuring

Change from Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument scores

Timeframe: 1 year

Trial details

NCT IDNCT06800404

SponsorHope Biosciences Research Foundation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Relapsing Remitting Multiple Sclerosis (RRMS) trials