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Stem Cell Therapy

Intravenous Infusion of UCLSCs for Angiodysplasia

Q: Are participants aged 45 or above being considered for this research?

The lower age limit for entry into this trial is 18 years of age, while the upper bound sits at 80.

Q: Are there any eligibility criteria for enrolling in this clinical experiment?

The research team is seeking 9 volunteers aged 18-80 with angiodysplastic bleeding. Additionally, applicants must have been taking <a href="https://www.withpower.com/clinical-trials/heart-failure">heart failure</a> medications for at least two weeks and without contraindications to these drugs; they should also possess an ejection fraction reduction and a durable centrifugal flow LVAD. These treatments will be provided in accordance to the clinically recommended dose.

Q: Is there still capacity for participants in this trial?

As confirmed on clinicaltrials.gov, the initial posting of this medical trial was on November 1st 2021 and the last update occurred in September 12th 2022; however, patient recruitment has since been discontinued. Nevertheless, 363 other trials are actively recruiting participants at present.

Phase < 1

Waitlist Available

Led By Mustafa Ahmed, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours

Awards & highlights

Study Summary

This trial will investigate whether it is safe to give Umbilical cord lining stem cells to people with Left Ventricular Assist Devices.

Eligible Conditions

Angiodysplasia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours

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

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Subjects with Dose Limiting Toxicity (DLT) that begins during or following ULSC infusion

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3+3 dose escalationExperimental Treatment1 Intervention

The first 3 subjects' patients will be administered 50 x 10^6 ULSCs reconstituted in PBS with 1% human serum albumin in a volume of 250 ml, and monitored for adverse events or toxicities, immediately following dosing, and again at 30 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intravenous Infusion of UCLSCs

2021

Completed Early Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,687 Total Patients Enrolled

Mustafa Ahmed, MDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

106 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged 45 or above being considered for this research?

"The lower age limit for entry into this trial is 18 years of age, while the upper bound sits at 80."

Answered by AI

Are there any eligibility criteria for enrolling in this clinical experiment?

"The research team is seeking 9 volunteers aged 18-80 with angiodysplastic bleeding. Additionally, applicants must have been taking heart failure medications for at least two weeks and without contraindications to these drugs; they should also possess an ejection fraction reduction and a durable centrifugal flow LVAD. These treatments will be provided in accordance to the clinically recommended dose."

Answered by AI

Is there still capacity for participants in this trial?

"As confirmed on clinicaltrials.gov, the initial posting of this medical trial was on November 1st 2021 and the last update occurred in September 12th 2022; however, patient recruitment has since been discontinued. Nevertheless, 363 other trials are actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding

2021. "u-STOP LVAD Bleed: Utilization of Umbilical Cord Lining Stem Cells (ULSCs) To Prevent Left Ventricular Assist Device (LVAD) Associated Angiodysplastic Bleeding". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04811261.