Phase 1 Sleep Disorders Trial, Recruiting NCT05682144 Sponsor: Immusoft of CA, Inc. Condition: Sleep Disorders
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Phase 1 Sleep Disorders Trial, Recruiting

NCT05682144
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with Mucopolysaccharidosis type I Hurler-Scheie or Scheie syndrome.
  • People who are 10 years of age or older at the time of registering for the study.
  • People whose kidneys are functioning well enough, as shown by a kidney filtering rate above a certain level (confirm with trial site for exact measurement method).
  • People whose heart is pumping effectively, as confirmed by a heart ultrasound showing the heart is working at or above the required level.
  • People who are able and willing to travel to the study site for required check-up appointments.
  • People who are able to stay within a 45-minute drive of the study site for at least 5 days after receiving the cell treatment.

Who may not be able to join:

  • People with a known inherited cancer syndrome that runs in their family, or those with a suspected case that is found to carry certain genetic mutations after testing.
  • People with a history of a cancer affecting B cells, a condition called EBV lymphoproliferative disease, or autoimmune disorders.
  • People who currently show signs of a condition called graft-versus-host disease (where previously transplanted cells attack the body).
  • People who have previously received a blood stem cell transplant.
  • People who currently need ongoing medication to suppress their immune system.
  • People who require continuous extra oxygen to breathe.
  • People with any other health condition that the medical team believes could interfere with assessing whether the treatment is safe or working.
  • People who, in the opinion of the study doctor, are unlikely to attend all required appointments or follow the study's requirements.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Immusoft of CA, Inc.
Registry
ClinicalTrials.gov
Start date
12 April 2023
Est. completion
1 June 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with treatment-related adverse events and serious adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov