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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~1year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1year for reporting.

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 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous Plasmablasts (B cells)Experimental Treatment1 Intervention
Dose Level: 5 x 10e7 cells/kg on Day 0

Find a Location

Who is running the clinical trial?

Immusoft CorporationLead Sponsor
Immusoft of CA, Inc.Lead Sponsor
Immusoft Clinical DevelopmentStudy DirectorImmusoft of CA, Inc.

Media Library

ISP-001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05682144 — Phase 1
Hurler Syndrome Research Study Groups: Autologous Plasmablasts (B cells)
Hurler Syndrome Clinical Trial 2023: ISP-001 Highlights & Side Effects. Trial Name: NCT05682144 — Phase 1
ISP-001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05682144 — Phase 1

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
~1 spots leftby Jun 2025