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Lomecel-B Injection for Hypoplastic Left Heart Syndrome (ELPIS II Trial)
ELPIS II Trial Summary
This trial is testing whether Lomecel-B can help repair the heart in patients with HLHS.
ELPIS II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELPIS II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ELPIS II Trial Design
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Who is running the clinical trial?
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- I am having the Norwood procedure but do not have hypoplastic left heart syndrome.I have a pacemaker or will get one before my Stage II treatment.I need a device to help my heart pump blood right before my second heart surgery.You have tested positive for HIV, hepatitis B, or hepatitis C. This can be confirmed by a documented history of testing during pregnancy, a documented history of your own testing, or a blood test at the screening or baseline.I need surgery for heart valve repair or to fix narrowing of my aorta.I have HLHS and need a Stage II heart surgery.You are allergic to dimethyl sulfoxide (DMSO).
- Group 1: Lomecel B Group
- Group 2: No Study Intervention Control Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What hazards may be associated with using Lomecel-B medicinal signaling cells?
"The safety of Lomecel-B medicinal signaling cells was assessed as a 2 due to the Phase 2 trial status, meaning there is no evidence supporting efficacy but some data confirming its security."
How many participants are signing up for the experiment?
"To initiate this trial, 38 volunteers who meet the pre-determined criteria must sign up. Locations participating in these trials include Primary Children's Hospital/University of Utah and Cincinnati Children's Hospital Medical Center."
In what geographic areas is this research endeavor being conducted?
"This clinical trial is presently in progress at 7 research centres. These sites are located across Salt Lake City, Cincinnati, Chicago and other municipalities. It is recommended that individuals choose the closest location to them if they decide to partake as it will reduce their commuting burden."
Are there opportunities for volunteers to participate in this experiment?
"According to information provided on clinicaltrials.gov, this trial is actively recruiting patients with an initial posting date of June 25th 2021 and a last update occurring August 10th 2022."
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