ClinicalTrials.gg
Active, not recruitingNCT06800404MSUpdated Nov 20, 2025

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

A Phase 2 interventional study of Autologous HB-adMSCs in Relapsing Remitting Multiple Sclerosis (RRMS) and Multiple Sclerosis, sponsored by Hope Biosciences Research Foundation. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Hope Biosciences Research Foundation · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States — 26 open to participants now, 44 under way, 7 of them phase 3. Multiple Sclerosis, Relapsing-Remitting · United States.

Enrollment
157th of 175
10 · median 65
Started
2025
with 9 others
Phase 2
40 of 229
1 open now
Primary completion
2027-01
later than 21 of 43 live
Registered
214th of 229
by date

Among the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States, this one is the 157th largest by enrollment of the 175 interventional ones that give a count, is one of 10 that started in 2025, is one of 40 in phase 2, reaches primary completion later than 21 of the 43 other live ones, and was the 214th registered.

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 83 are open to participants now.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Open to participants now

26 of the 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States are open now. Recruiting first, the newest first:

21 more — sign in →

All 26 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 60 Multiple Sclerosis, Relapsing-Remitting studies recruiting now, 11 (18%) set no upper age limit and 43 (72%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 229 studies in Multiple Sclerosis, Relapsing-Remitting with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Relapsing Remitting Multiple Sclerosis (RRMS)
  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Relapsing Remitting Multiple Sclerosis
  • Stem Cells
  • Hope Biosciences
  • MS
  • RRMS
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female subjects 18 - 75 years of age.
  2. Study subjects must have been diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation.
  3. 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.)
  4. Study subjects must be stabilized on any MS therapy for at least 6 months prior to enrollment.
  5. Study subjects must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial.
  6. Study subjects must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk).
  7. Study subjects must have previously banked their mesenchymal stem cells with Hope Biosciences.
  8. Study subjects should be able to read, understand and to provide written consent.
  9. Before any clinical-trial-related procedures are performed, must be obtained from the subjects voluntarily.
  10. Female study subjects of should not be pregnant or plan to become pregnant during study participation and for 6 months after the last product administration. Female study subjects of childbearing potential should confirm the use of one of the following 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).
  11. 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:

    • 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 (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).
  12. Study subject is able and willing to comply with the requirements of this clinical trial.
  13. Subjects 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.

Exclusion criteria

Exclusion Criteria:

  1. Women who are currently pregnant or lactating.
  2. Study subject has any active , including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma.
  3. Study subject has known addiction or dependency or has current substance use or abuse.
  4. 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 \< 59mL/min/1.73m2
    • Presence of (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.
  5. Study subject has received any stem cell treatment within 12 months before first dose of product other than stem cells produced by Hope Biosciences.
  6. The study subject has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations)
  7. Study subject has a laboratory abnormality during screening, including the following:

    • White blood cell count \< 3000/mm3
    • count \< 80,000mm3
    • \< 1500/mm3
    • (ALT) or aspartate aminotransferase (AST) 10 (ULN) x 1.5
  8. 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.
  9. The study subject has any concurrent neurologic disease, including hereditary conditions that the principal investigator considers could interfere with the study participation. Some of these neurologic diseases could be Charcot-Marie-Tooth (CMT) or Spinocerebellar Ataxia (SCA).
  10. Study subject is unlikely to complete the study or adhere to the study procedures.
  11. Study subject has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
  12. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
  13. Male study subjects who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.
  14. Study subjects who are determined by the Investigator to be unsuitable for study enrollment for other reasons.
  15. Subjects' must not have been considerably limited by other comorbidities, a history of previous myelodysplasia, or hematologic illness.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Treatment

    Autologous adipose-derived HB-adMSCs

    Drug: Autologous HB-adMSCs

Interventions

  • DrugAutologous HB-adMSCs

    Autologous HB-adMSCs

06

What researchers measure

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).

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Incidence of serious Adverse Events (SAEs)

    Incidence of serious Adverse Events (SAEs)

    Time frame: 1 year

  5. 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

  6. 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

  7. 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

  8. Clinically significant changes in weight

    Clinically significant changes in weight (measured in pounds)

    Time frame: 1 year

  9. Clinically significant changes in physical examination results

    Clinically significant changes in physical examination results

    Time frame: 1 year

  10. Clinically significant changes in Multiple Sclerosis concomitant medications

    Clinically significant changes in Multiple Sclerosis concomitant medications

    Time frame: 1 year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Jan 2027, 20 months after the start.

Of 25 phase 2 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 67. This study's planned 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2025
First posted
Jan 30, 2025
StartActual
May 2, 2025
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Nov 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06800404
Responsible party
Sponsor
First posted
Jan 30, 2025
Start date
May 2, 2025
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Nov 20, 2025

Study contacts

Djamchid Lotfi, MD
principal investigator · Hope Biosciences Research Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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