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Cell Therapy

Hepatocyte Transplant for Phenylketonuria

Phase 1 & 2

Waitlist Available

Led By Ira J Fox, MD

Research Sponsored by Ira Fox

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for PKU that involves transplanting liver cells.

Eligible Conditions

Phenylketonuria

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement/reversal of characteristics of PKU

Secondary outcome measures

Adaptive Behavior Assessment System-third edition (ABAS-III)

Beck Depression Inventory

Behavior Assessment System for Children-second edition (BASC-II)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hepatocyte TransplantationExperimental Treatment7 Interventions

See Below.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liver Biopsy

2015

N/A

~270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ira FoxLead Sponsor

2 Previous Clinical Trials

5 Total Patients Enrolled

Ira J Fox, MDPrincipal InvestigatorUniversity of Pittsburgh

2 Previous Clinical Trials

5 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are involved in this clinical trial?

"That is accurate. The information available on clinicaltrials.gov does show that this trial is looking for participants. According to the site, the study was originally posted on December 15th, 2022 and was last edited on January 6th, 2022. They are hoping to enroll 10 patients from 1 location."

Answered by AI

Are there any more patients needed to participate in this experiment?

"Correct, this study detailed on clinicaltrials.gov is currently recruiting. The listing was first posted on December 15th, 2020 and updated January 6th, 2021."

Answered by AI

Are there any prerequisites for enrolling in this clinical trial?

"This study is seeking 10 patients with phenylketonuria that are aged 14 to 55. The most crucial requirements are as follows: a recent comprehensive evaluation at a PKU clinic within the last year, age between the specified thresholds, and being willing/able to complete all study procedures and remain available for the entirety of the trial."

Answered by AI

For this particular experiment, are test subjects being sourced from individuals aged 30 or older?

"According to the inclusion criteria laid out for this trial, patients must be between 14 and 55 years old. There are 16 similar studies available for people below the age of 18 and 13 for those above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Liver Cell Transplant for Phenylketonuria

Ira Fox 2011. "Liver Cell Transplant for Phenylketonuria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01465100.