Autologous EPCs transfected with human eNOS for Hypertension, Pulmonary

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. Joseph's Hospital (McMaster University), Hamilton, Canada
Hypertension, Pulmonary+2 More
Autologous EPCs transfected with human eNOS - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a treatment that increases blood flow to the lungs can improve symptoms in people with pulmonary arterial hypertension.

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Eligible Conditions

  • Hypertension, Pulmonary
  • Hypertension,Pulmonary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hypertension, Pulmonary

Study Objectives

This trial is evaluating whether Autologous EPCs transfected with human eNOS will improve 6 secondary outcomes in patients with Hypertension, Pulmonary. Measurement will happen over the course of 12 months.

12 months
Change in Echocardiography Right Ventricular (RV) Function Measures from Baseline
Change in Magnetic Resonance Imaging Right Ventricular (RV) Function Measures from Baseline
Change in Quality of Life Measures from Baseline
Number of Deaths or Clinical Worsening of Pulmonary Arterial Hypertension
3 and 9 months
Change in 6 Minute Walk Distance (6MWD) from Baseline
Change in Pulmonary Vascular Resistance from Baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hypertension, Pulmonary

Trial Design

3 Treatment Groups

Autologous EPCs transfected with eNOS
1 of 3
Autologous EPCs transfected with eNOS followed by Placebo
1 of 3
Placebo followed by Autologous EPCs transfected with eNOS
1 of 3
Experimental Treatment

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. Autologous EPCs Transfected With Human ENOS is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Autologous EPCs transfected with eNOS
Biological
4 monthly IV injections of Autologous EPCs transfected with human eNOS in Course 1 followed by 4 monthly injections of Autologous EPCs transfected with human eNOS in Course 2 (total of 160 million cells)
Autologous EPCs transfected with eNOS followed by Placebo
Biological
4 monthly IV injections of Autologous EPCs transfected with human eNOS (total of 80 million cells) during Course 1 followed by 4 monthly IV injections of Placebo (Plasma-Lyte A) during Course 2
Placebo followed by Autologous EPCs transfected with eNOS
Biological
4 monthly IV injections of Placebo (Plasma-Lyte A) during Course 1 followed by 4 monthly IV injections of Autologous EPCs transfected with human eNOS (total of 80 million cells) during Course 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 and 9 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 and 9 months for reporting.

Closest Location

St. Joseph's Hospital (McMaster University) - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years, ≤ 80 years
Idiopathic or heritable PAH;
Scleroderma associated PAH (limited or diffuse);
Drugs (anorexigens) or toxins;
Congenital heart defects (atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired ≥ 1 years
WHO functional class II, III, or IV on appropriate stable therapy for PAH for at least 3 months prior to the screening period and up until randomization, apart from modification of anticoagulant or diuretic dosages, or small adjustments in prostaglandin dose that are considered by the Investigator to be consistent with stable parenteral therapy.
Able to walk unassisted (oxygen use allowed). Aids for carrying oxygen (such as a wheel chair or walker) are permitted provided they are not also required as mobility aids.
An average 6-Minute Walk Distance (6MWD) of ≥ 125 meters and ≤ 440 meters on two consecutive tests during the Screening period
Previous diagnostic right heart cardiac catheterization (RHC) at the time of PAH diagnosis with findings consistent with PAH: specifically, mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest); pulmonary vascular resistance (PVR) ≥ 3 WU; pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤12 mmHg if PVR ≥ 3 to < 5 WU, or pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤ 15 mmHg if PVR ≥ 5 WU. If repeat testing has occurred since initial diagnosis, the most recent results should be used.
Echocardiography performed within 12 months prior to the Screening Period confirming a left atrial volume index (LAVI) of ≤ 34 ml/m2 and the absence of any clinically significant left heart disease including evidence of more than mild left-sided valvular heart disease, systolic or diastolic left ventricular dysfunction

Patient Q&A Section

Can hypertension, pulmonary be cured?

"In China, patients with hypertension have a lower risk of death from cardiovascular disease than the general population when treated to the treatment guideline. Thus, the treatment for hypertension in China is beneficial. More rigorous and extensive clinical studies are needed to support the treatment guidelines." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypertension, pulmonary?

"The signs of pulmonary hypertension include:\n\n1. shortness of breath\n\n2. a raised jugular pressure\n\n3. blue sclera in the periphery\n\n4. ascites, and a loud heart, diastolic and systolic murmurs that are best heard with a stethoscope.\n\n5. a blue tinge to the lips\n\n6. blue skin\n\n7. a muffled heart sound\n\n8. a systolic murmur\n\n9. diastolic murmur\n\n10. palpitations\n\n11." - Anonymous Online Contributor

Unverified Answer

What is hypertension, pulmonary?

"Hypertension, pulmonary is the third leading cause of death in the United States. It is usually a result of heart disease. Hypertension, pulmonary affects many parts of the body, the heart being the first part of the system to show effects. In order for an individual to be affected, hypertension, pulmonary will need to be a part of their overall health and fitness. If an individual who has experienced this illness prior has the chance to prevent it from ever taking their lives, it is important to understand the symptoms, causes, and treatments as well as how to recognize if the individual has the disease." - Anonymous Online Contributor

Unverified Answer

What causes hypertension, pulmonary?

"The prevalence of hypertension is similar in men and women; however, it is more prevalent in smokers. Hypertension often occurs together with hypertension in elderly people. In children, high blood pressure and low physical activity are risk factors for hypertension. In particular, smoking and alcohol consumption have an adverse effect on hypertension, whereas in older adults smoking and drinking decrease blood pressure and this is associated with a reduced risk of death." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypertension, pulmonary?

"The presence of a secondary diagnosis is a contraindication to use of ACE inhibitors for treatment of hypertension. If there is no contraindication to ACE inhibitor use, they remain an effective and safe option for treatment of hypertension." - Anonymous Online Contributor

Unverified Answer

How many people get hypertension, pulmonary a year in the United States?

"A year ago, nearly 2.5 million Americans were new cases of hypertension, and 862,000 new cases of pulmonary hypertension were recorded. This is a 5% increase in new hypertension cases and a 15% increase in new pulmonary hypertension cases compared with 1998." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of autologous epcs transfected with human enos?

"autologous epidCS transfection can produce effective and safe immunization in alloxan-induced diabetic rats. autologous epidCS transfection can also produce effective vaccine and effective immunization in allergenic rats, but the immunizing efficacy of this vaccine is poor in both models." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hypertension, pulmonary?

"Primary hypertension, especially in older persons (60 years or more), is mainly caused by increased resistance in the pulmonary circulation and increased capillary pressure. It is characterized by high pulmonary vascular resistance and low capillary blood flow. Most cases are attributable to the chronic high levels of blood pressure that develop slowly over time in hypertensive persons." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hypertension, pulmonary?

"Hypertension is the single greatest risk factor for death and disability among people with chronic disease. While hypertension is a great obstacle to many people with chronic disease, the majority lack a well-equipped treatment unit. Physicians have a responsibility and an opportunity to advance the treatment and management of chronic disease. Our literature review shows an improvement in the quality of the research and the advancements in the understanding of chronic disease. We expect the greatest improvements in the management of chronic disease to be in the future." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hypertension, pulmonary?

"Almost 8 in 10 persons with hypertension, pulmonary got their first diagnosis after the age of 50, particularly in men. As these data reflect an emerging cohort of patients with hypertension, prevention campaigns should address individuals with greater than average age at diagnosis." - Anonymous Online Contributor

Unverified Answer

Does autologous epcs transfected with human enos improve quality of life for those with hypertension, pulmonary?

"Autologous EPCS transfected with human rEN gene improves quality of life for patients with hypertension or pulmonary hypertension, possibly by suppressing proinflammatory pathways. EPCS-derived protein could be an effective target for therapy of these chronic diseases." - Anonymous Online Contributor

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