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Relapsing Remitting Multiple Sclerosis (RRMS)Phase 2MSNCT06800404

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

A Phase 2 study testing Autologous HB-adMSCs in people with Relapsing Remitting Multiple Sclerosis (RRMS) and Multiple Sclerosis, run by Hope Biosciences Research Foundation at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Autologous HB-adMSCs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
2 May 2025to Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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:
  • 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)).
  • Study subject is able and willing to comply with the requirements of this clinical trial.
  • 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.

Who cannot join

  • 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
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  • 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
  • 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 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.
  • 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).
  • Study subject is unlikely to complete the study or adhere to the study procedures.
  • Study subject has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
  • Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
  • 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.
  • Study subjects who are determined by the Investigator to be unsuitable for study enrollment for other reasons.
  • Subjects' life expectancy must not have been considerably limited by other comorbidities, a history of previous myelodysplasia, or hematologic illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hope Biosciences Research Foundation

    Sugar Land, Texas, 77479

Other trials in United States

About this study

Official title: "A Phase 2, Open Label, Efficacy and Safety Study of Autologous HB-adMSCs for the Treatment of Patients With Multiple Sclerosis"

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.

Being tested
Autologous HB-adMSCs
Keywords
Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Stem Cells, Hope Biosciences, MS, RRMS
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous HB-adMSCsDrug

    Autologous HB-adMSCs

Study groups in NCT06800404
Study groupRoleWhat they receive
TreatmentExperimentalAutologous adipose-derived HB-adMSCs
Receives: Drug: Autologous HB-adMSCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 1 year

  3. Incidence of treatment-emergent Adverse Event (TEAEs)

    The number of patients and count of TEAEs of all patients in the study

    Measured: 1 year

  4. Incidence of serious Adverse Events (SAEs)

    Incidence of serious Adverse Events (SAEs)

    Measured: 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.

    Measured: 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)

    Measured: 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)

    Measured: 1 year

  8. Clinically significant changes in weight

    Clinically significant changes in weight (measured in pounds)

    Measured: 1 year

  9. Clinically significant changes in physical examination results

    Clinically significant changes in physical examination results

    Measured: 1 year

  10. Clinically significant changes in Multiple Sclerosis concomitant medications

    Clinically significant changes in Multiple Sclerosis concomitant medications

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2025
  2. Study start2 May 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06800404
Sponsor's protocol ID
HBMS02
Acronym
MS
Status last verified
Nov 2025
First submitted
17 Jan 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous HB-adMSCs in people with Relapsing Remitting Multiple Sclerosis (RRMS) and Multiple Sclerosis, run by Hope Biosciences Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument scores (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06800404.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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