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

NCT06800404 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HBMS02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS); Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Stem Cells; Hope Biosciences; MS; RRMS

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (10)

• Change from Baseline in Expanded Disability Status Scale (EDSS) scores

  1 year

• Change from Baseline in Patient Health Questionnaire (PHQ-9) scores

  1 year

• Incidence of treatment-emergent Adverse Event (TEAEs)

  1 year

• Incidence of serious Adverse Events (SAEs)

  1 year

• Incidence of AEs of special interest (serious or nonserious)

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Autologous adipose-derived HB-adMSCs

Drug: Autologous HB-adMSCs

Interventions

Autologous HB-adMSCs DRUG

Autologous HB-adMSCs

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Before any clinical-trial-related procedures are performed, informed consent must be obtained from the subjects voluntarily.
• Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential should confirm the use of one of the following contraceptive measures:
• Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
• Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
• Barrier contraceptive methods (condoms, diaphragm, etc.).
• Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).
• Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:

You may not qualify if:

• 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:
• 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 \< 59mL/min/1.73m2
• Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit.
• Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina.
• Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure \> 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 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:
• White blood cell count \< 3000/mm3

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Research Foundation

Sugar Land, Texas, 77479, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)