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Virus Therapy
Engineered B Cell Therapy for Mucopolysaccharidosis I
Phase 1
Recruiting
Research Sponsored by Immusoft Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must agree to stay <45-minute drive from the study site for a minimum of 5 days after cell infusion.
Must commit to traveling to the study site for the necessary follow-up evaluations.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1year
Awards & highlights
Study Summary
This trial tested a possible treatment for a rare genetic disorder, Mucopolysaccharidosis Type I, in adults.
Who is the study for?
Adults over 18 with Mucopolysaccharidosis type I Hurler-Scheie or Scheie can join this trial. They must live close to the study site, have good kidney function and heart health, and be able to attend all follow-ups. Those with certain medical conditions, oxygen needs, immune suppression, past stem cell transplants or B cell cancers cannot participate.Check my eligibility
What is being tested?
The trial is testing a new treatment using patients' own modified B cells (ISP-001) for adults with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie. It's a first-of-its-kind study focusing on safety and how well it works in humans.See study design
What are the potential side effects?
As this is a first-in-human study of ISP-001, specific side effects are not yet known but may include typical risks associated with cellular therapies such as immune reactions, infusion-related symptoms, and potential impacts on blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can stay within a 45-minute drive from the study site for at least 5 days after treatment.
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I can travel to the study site for follow-up visits.
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I am 18 years old or older.
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I have been diagnosed with a form of Mucopolysaccharidosis (MPS I).
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My kidneys are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Analysis of PBMCs
Assessment of Storage Material (glycosaminoglycan, or GAG)
Concentration of IDUA
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Autologous Plasmablasts (B cells)Experimental Treatment1 Intervention
Dose Level: 5 x 10e7 cells/kg on Day 0
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Who is running the clinical trial?
Immusoft CorporationLead Sponsor
Immusoft of CA, Inc.Lead Sponsor
Immusoft Clinical DevelopmentStudy DirectorImmusoft of CA, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of B cell cancer, EBV disease, or autoimmune disorders.I need medication to suppress my immune system.I can stay within a 45-minute drive from the study site for at least 5 days after treatment.I have a genetic condition that increases my cancer risk.I can travel to the study site for follow-up visits.I am experiencing symptoms of graft-vs-host disease.I have had a stem cell transplant before.I am 18 years old or older.I have been diagnosed with a form of Mucopolysaccharidosis (MPS I).Your heart pumps blood at a normal rate, as shown on an echocardiogram.I need extra oxygen all the time.My kidneys are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Plasmablasts (B cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots for participants in this experiment?
"According to clinicaltrials.gov, this medical experiment is not currently taking on new participants; the trial was first published on January 15th 2023 and most recently adjusted on the 11th of that same month. Nevertheless, there are presently 30 other trials recruiting patients right now."
Answered by AI
Has the federal government sanctioned Autologous Plasmablasts (B cells) for clinical use?
"Due to the limited data available, our team assessed Autologous Plasmablasts (B cells) as a 1 on a scale of safety from 1-3. This is in keeping with it being classified as a Phase 1 trial."
Answered by AI
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