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Could your own stem cells ease MS symptoms? new trial tests idea

NCT ID NCT05116540

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a person's own stem cells (called HB-adMSCs) could improve quality of life for people with multiple sclerosis. Twenty-four adults with relapsing-remitting MS received either the stem cells or a placebo through six infusions over a year, while continuing their usual MS medications. The main goal was to see if the treatment improved physical and mental well-being, as measured by a detailed quality-of-life questionnaire.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Nov 2021

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female participants 18 - 75 years of age. 2. Study participants must have been diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) for at least 6 months before study participation. 3. Study participants must be stabilized on any MS therapy for at least 6 months prior to randomization. 4. Study participants must agree not to increase or begin any Diseases Modifying Therapies for MS during participation in the clinical trial. 5. Study participants must have an EDSS score between 3.0 to 6.5. (Patient must be able to walk). 6. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences. 7. Study participants should be able to read, understand, and provide written consent. 8. Before any clinical-trial-related procedures are performed, informed consent must be obtained from the participants voluntarily. 9. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. \* 10. Male participants, if their sexual partners can become pregnant, should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. \* 11. Study participant is able and willing to comply with the requirements of this clinical trial. 12. Participants 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, and no other signs of relapse. Exclusion Criteria: 1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. \* 2. Study participants with other types of multiple sclerosis, such as progressive relapsing, primary or secondary progressive. 3. Study participant has any active malignancy, including but not limited to evidence of cutaneous basal, squamous cell carcinoma, or melanoma. 4. Study participant has known addiction or dependency or has current substance use or abuse. 5. Study participant 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. 6. Study participant has received any stem cell treatment within 12 months before first dose of investigational product other than stem cells produced by Hope Biosciences. 7. The study participant has received any experimental drug within 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations) 8. Study participant 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 9. Study participant 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. 10. The study participant 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). 11. Study participant has any ongoing infection, including TB, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV, or syphilis infections, as well as hepatitis B surface antigen positive, and or/ hepatitis C PCR positivity. 12. Study participant is unlikely to complete the study or adhere to the study procedures. 13. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments. 14. Study participants with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product. 15. Male study participants 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. 16. Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons. 17. Participants' life expectancy must not have been considerably limited by other comorbidities, a history of previous myelodysplasia, or hematologic illness. * Acceptable reversible and permanent methods of birth control include: 1\. True sexual abstinence (abstaining from sexual activity during the entire period of risk). 2\. Surgery (occlusion bilateral tubal ligation, vasectomized partner). 3. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable patch, or intravaginal). 4. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hope Biosciences Stem Cell Research Foundation

    Sugar Land, Texas, 77478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.