What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis with regenerative and immunomodulatory properties, such as hematopoietic stem cell transplantation (HSCT), alemtuzumab, and fingolimod, have notable side effects. HSCT can cause serious complications like infections, organ toxicity, and even death. Alemtuzumab increases the risk of infections and autoimmune disorders, including immune thrombocytopenia. Fingolimod's side effects include headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased susceptibility to infections. These treatments require careful management due to their significant risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that have immunomodulatory properties. Hematopoietic stem cell transplantation (HSCT) has shown promise in treating highly active relapsing-remitting MS by resetting the immune system. Other FDA-approved drugs include dimethyl fumarate (BG-12), which reduces relapse rates and new brain lesions, and glatiramer acetate, which modulates the immune response. While specific regenerative therapies like autologous HB-adMSCs are still under investigation, these approved treatments highlight the ongoing efforts to manage MS through immune system modulation and potential regenerative approaches.

What other types of research exist?

Promising alternatives to Autologous HB-adMSCs for MS patients include Alemtuzumab and oral formulations of Dimethyl Fumarate (BG-12). Alemtuzumab has shown efficacy in reducing relapse rates in relapsing-remitting MS (RRMS) but comes with a risk of serious infections and autoimmune disorders. Dimethyl Fumarate has demonstrated significant reductions in relapse rates and new brain lesions, with a favorable safety profile. Both therapies are supported by data from randomized controlled trials and are viable options for MS treatment in 2024.

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Stem Cell Therapy

Autologous HB-MSCs for Multiple Sclerosis (HBMS01 Trial)

Phase 2

Waitlist Available

Led By Djamchid Lotfi, MD

Research Sponsored by Hope Biosciences Stem Cell Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52

Summary

This trial is testing a treatment that uses a patient's own stem cells to help repair nerve damage caused by Multiple Sclerosis. The treatment involves several infusions over time. The goal is to see if these special cells can reduce symptoms and improve safety. Mesenchymal stem cells (MSCs) have been widely investigated as a potential treatment for multiple sclerosis due to their regenerative capabilities.

Who is the study for?

Adults aged 18-75 with Relapsing-Remitting Multiple Sclerosis, stabilized on MS therapy for at least 6 months. They must have banked stem cells with Hope Biosciences and not be pregnant or planning pregnancy. Contraception is required during the trial and for six months after. Excludes those with other MS types, active cancer, substance abuse, severe comorbidities, recent stem cell treatments (except from Hope Biosciences), or experimental drugs within a year.

What is being tested?

The study tests the efficacy and safety of Autologous HB-adMSCs against a placebo in treating Multiple Sclerosis over one year. It involves 24 participants receiving six infusions while continuing their regular MS medications.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to infusion therapies such as discomfort at injection site, fever, chills, headache, nausea or allergic reactions; specific risks will depend on patient's condition and treatment response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To investigate the efficacy of intravenous infusions of HB-adMSCs vs placebo in patients with Multiple Sclerosis as determined by improvements in the Multiple Sclerosis Quality of Life (MSQOL) 54 Instrument.

Secondary study objectives

To assess the safety of intravenous infusions of HB-adMSCs vs. Placebo in patients with Multiple Sclerosis as determined by the incidence of adverse events or serious adverse events

To determine the efficacy of intravenous infusions of HB-adMSCs vs. Placebo in patients with Multiple Sclerosis as determined by changes in 9-Hole Peg Test

To evaluate the efficacy of intravenous infusions of HB-adMSCs vs placebo in patients with Multiple Sclerosis as determined by changes in the Barthel Index

+2 more

Side effects data

From 2021 Phase 2 trial • 53 Patients • NCT04348435

25%

Headache

17%

Muscle fatigue

Urinary tract infection

Fracture

Appendicectomy

Rotator cuff repair

Myalgia

Hypoaesthesia

Pain

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Allogeneic HB-adMSCs 50MM

Allogeneic HB-adMSCs 200MM

Allogeneic HB-adMSCs 100MM

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Adipose derived Mesenchymal stem cells (Autologous)

Group II: PlaceboPlacebo Group1 Intervention

Normal Saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HB-adMSCs

2020

Completed Phase 2

~170

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) often focus on immunomodulation and neuroprotection. Disease-modifying therapies (DMTs) like dimethyl fumarate and glatiramer acetate work by modulating the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath. Autologous hematopoietic stem cell transplantation (HSCT) aims to reset the immune system by eliminating the existing immune cells and allowing new, non-autoimmune cells to develop. Similarly, treatments like Autologous HB-adMSCs leverage regenerative and immunomodulatory properties to repair damaged tissues and modulate immune responses. These mechanisms are crucial for MS patients as they help slow disease progression, reduce relapse rates, and potentially repair neurological damage, thereby improving quality of life.

Disease-modifying treatments for progressive multiple sclerosis.