STRO4 for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the treatment STRO4, administered through an IV, is safe and effective for individuals with ALS, a disease affecting nerve cells in the brain and spinal cord. The trial aims to assess the treatment's ability to slow down or improve ALS symptoms. Individuals diagnosed with ALS within the past two years and who have manageable breathing issues may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that STRO4 is likely to be safe for humans?
Research has shown that treatments like STRO4, which use stem cells administered through an IV, have been safe for people with ALS. In one study, patients who received these treatments tolerated them well, with no major safety issues reported. Most side effects were mild and resolved quickly. This suggests that STRO4 might also be safe. However, since STRO4 remains under investigation, more information is needed to fully understand its safety.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for ALS, which primarily focus on managing symptoms, STRO4 is unique because it targets the disease's progression at a molecular level. Researchers are excited about STRO4 because it offers a novel mechanism of action that aims to protect and repair nerve cells, potentially slowing down the degeneration process. This approach could lead to not just symptomatic relief but also a meaningful impact on the disease's course, offering hope for improved outcomes for patients with ALS.
What evidence suggests that STRO4 might be an effective treatment for ALS?
A previous study showed that STRO4 holds promise in treating Amyotrophic Lateral Sclerosis (ALS). Research suggests that this treatment targets specific processes in the body linked to nerve damage. Early results indicate that STRO4 may help slow the progression of ALS, a disease that gradually weakens muscles. Although human studies have provided limited information, the initial signs are hopeful for its effectiveness. Since ALS progresses quickly, any treatment that can slow it down is valuable.12678
Who Is on the Research Team?
Alan Jacobs, MD, PhD
Principal Investigator
New England Cell Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for people with ALS, diagnosed as 'Definite' or 'Probable', within 2 years of onset. They should be in the early stages (grade 1 or 2) and have certain breathing capabilities (%FVC of 80%+). Participants must not have a current viral infection, low blood cell counts, cancer history, congenital malformations, chromosomal abnormalities, or serious allergies including to penicillin or streptomycin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Collection of peripheral blood and bone marrow for the manufacture of STR04
Treatment
Participants receive 4 doses of STR04, one dose every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- STRO4
Find a Clinic Near You
Who Is Running the Clinical Trial?
New England Cell Therapeutics, Inc.
Lead Sponsor