Intravenous Infusion of UCLSCs for Hemorrhage

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Florida, Gainesville, FL
+1 More
Intravenous Infusion of UCLSCs - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hemorrhage

Study Summary

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

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Eligible Conditions

  • Hemorrhage
  • Angiodysplastic Bleeding

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Intravenous Infusion of UCLSCs will improve 1 primary outcome in patients with Hemorrhage. Measurement will happen over the course of Within 24 hours.

Within 24 hours
Number of Subjects with Dose Limiting Toxicity (DLT) that begins during or following ULSC infusion

Trial Safety

Trial Design

2 Treatment Groups

Control
3+3 dose escalation

This trial requires 9 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intravenous Infusion Of UCLSCs is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

3+3 dose escalation
Drug
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 24 hours for reporting.

Closest Location

University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient should be on a stable regimen of heart failure medications for at least two weeks, including ACE/ARB/ARNi unless there is a documented contraindication to their use show original
You must be at least 18 years old to qualify for this offer. show original
implanted The patient has heart failure with a reduced ejection fraction and has had a durable centrifugal flow LVAD implanted. show original

Patient Q&A Section

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

What causes hemorrhage?

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The development of hemorrhage is a complex process, involving complex interactions between hemodynamic and metabolic factors and the effects of various factors. The most important of these factors are hemostatic factors--specifically fibrin glue and collagen in the wall of the blood vessels. Hemorrhage is also strongly associated with other factors, including dehydration and inflammation.

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Can hemorrhage be cured?

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Blood-thinning treatment can effectively stop bleeding from a ruptured artery. Treatment of hemorrhage can be effective, therefore bleeding from the uterine septum and other obstetrical hemorrhagic disorders can be cured.

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What are the signs of hemorrhage?

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Findings from a recent study of this study, taken together with the findings of a study that included trauma patients, indicate that the clinical signs at presentation in patients with traumatic hemoptysis, when associated with other injuries, are nonspecific. Patients with traumatic hemoptysis should not be assumed to be victims of an underlying life-threatening injury such as a hematoma or pulmonary embolism.

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What is hemorrhage?

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Hemorrhage is a loss of blood and/or fluid from the blood vessels into the soft body tissues and/or the extracellular fluids of the body. It is an important part of the pathogenesis of shock. It is a potentially life-threatening condition.\n

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How many people get hemorrhage a year in the United States?

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There are about 23 million Americans with hemorrhage. Males are more commonly injured by bleeding than females. A minority of people with hemorrhage are hospitalized. There are about 40000 American people hospitalized every year, about half of whom die from the hemorrhage before they become hospitalized.

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What are common treatments for hemorrhage?

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The goals of treatment are to stop bleeding, to reduce the risk of rebleeding and to maximize outcomes. Common treatments include hemostatic agents, medications, and surgery. However, these are not always effective and are often expensive.

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How does intravenous infusion of uclscs work?

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Under our experimental conditions, uclsc treatment significantly suppressed neutrophil chemiluminescence in blood. While uclsc treatment and the control did not affect the level of serum IL-1. However, the experimental group showed significant increase of serum IL-1 ratio. Thus, uclsc could be considered a potent biological reagent for the treatment of hemorrhagic shock and its complications.

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How serious can hemorrhage be?

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There are [no standards of care to provide in the treatment of hemorrhages] such as the [hemorrhage] guideline by the United Kingdom's National Institute for Health and Clinical Excellence (NICE)(http://wwwnict.nih.com.au/hb/index.aspx) that should be followed when patients are admitted for treatment to a hospital; more research is needed before such a guideline can be recommended. Hemorrhage can sometimes be devastating to patients and cause death, so treatment and education to first aid providers is essential. For this purpose, you can find the latest guidelines by NICE or [Power (https://www.withpower.

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Is intravenous infusion of uclscs typically used in combination with any other treatments?

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The administration of uclscs appears to be in the majority of cases useful in uncomplicated patients admitted to the ward wards, but not in those subjected to concomitant treatment. A prospective randomized study would be necessary to define and validate the most effective treatment approach.

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Does hemorrhage run in families?

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Findings from a recent study did not support the widely held view that the hemorrhagic tendency of hemophiliac families is a genetically based condition. Rather, these families appear to have a hereditary tendency to develop hematuria.

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What does intravenous infusion of uclscs usually treat?

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IVUS has shown a possible benefit to some cases, however, it is still inconclusive for the treatment of intracranial hematomas. In case no improvements are reported of patients who have gone through such a therapy, this could be a sign of an inefficient treatment, leading to a relapse. Until now, no results have been obtained using a subdural injection of (Uclosc/Solase) as an adjuvant treatment for intracranial hematomas.

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What are the common side effects of intravenous infusion of uclscs?

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Tachycardia, hypotension, fever, and pain are the most commons side effects of uclscs in a short term. More rigorous trials are needed with a larger size to confirm our conclusion.

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