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Virus Therapy
NAN-101 for Heart Failure (NAN-CS101 Trial)
Phase 1
Recruiting
Research Sponsored by Asklepios Biopharmaceutical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years of age
Chronic non-ischemic cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at screening, 18-24 hours post intervention, week 4, month 6 and month 12
Awards & highlights
NAN-CS101 Trial Summary
This trial is testing a new treatment for heart failure. Up to 12 patients will receive an infusion of the investigational product. All patients will be followed for up to 36 months.
Who is the study for?
This trial is for adults over 18 with Class III heart failure who've had symptoms despite treatment for at least 6 months. They must have a left ventricular ejection fraction (LVEF) ≤30% and be able to consent. Women of childbearing age and men must agree to use contraception during the study and for six months after.Check my eligibility
What is being tested?
The trial tests a single intracoronary infusion of NAN-101 in patients with symptomatic congestive heart failure, monitoring them for safety, feasibility, and efficacy over a period of up to three years including follow-ups via phone every six months after the first year.See study design
What are the potential side effects?
As this is an early-phase trial primarily assessing safety, specific side effects are not listed but may include typical risks associated with intracoronary procedures such as bleeding or infection, as well as any potential gene therapy-related reactions.
NAN-CS101 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have a long-term heart condition that is not caused by blocked arteries.
NAN-CS101 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at screening, 18-24 hours post intervention, week 4, month 6 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at screening, 18-24 hours post intervention, week 4, month 6 and month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Observed and change from baseline in Echocardiographic assessment in Left Ventricular Ejection Fraction
Observed and change from baseline in Peak VO2
Secondary outcome measures
Observed and change from baseline in 6-minute walk test distance
NAN-CS101 Trial Design
3Treatment groups
Experimental Treatment
Group I: 3 x 10e14 vg NAN-101Experimental Treatment1 Intervention
Intracoronary Infusion of NAN-101 3 x 10e14 vg up to 4 subjects
Group II: 3 x 10e13vg NAN-101Experimental Treatment1 Intervention
Intracoronary Infusion of NAN-101 at 3 x 10e13vg up to 4 subjects
Group III: 1 x 10e14vg NAN-101Experimental Treatment1 Intervention
Intracoronary Infusion of NAN-101 1 x 10e14vg up to 4 subjects
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Who is running the clinical trial?
Asklepios Biopharmaceutical, Inc.Lead Sponsor
7 Previous Clinical Trials
421 Total Patients Enrolled
1 Trials studying Heart Failure
150 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have anemia or needed a blood transfusion in the last 30 days.I am older than 18 years.I haven't taken part in another clinical study or taken any investigational drugs within the last 30 days.Your heart's pumping ability is very low, as measured by a recent heart ultrasound.I am a man who can father a child and agree to use a condom for 6 months after treatment.I am allergic to dyes used in certain heart and blood vessel imaging tests.I am on dialysis or my kidney function test shows creatinine over 2.5 mg/dl.I have a long-term heart condition that is not caused by blocked arteries.You have a severe heart block.My heart doctor agrees I can have the specific heart procedure.I have long-term heart muscle damage from reduced blood flow.I can sign the consent and medical release forms.I have AIDS, am HIV-positive, or have a low neutrophil count.I have had heart surgery or a device implanted for heart support.My white blood cell count is low.I do not have specific heart or thyroid conditions.I haven't had IV heart support or mechanical heart aid in the last 30 days.I have not had heart surgery or a heart procedure in the last 30 days.I am likely to start specific treatments within 3 months after starting the trial medication.The doctor thinks you may not live for more than one year.I have had heart failure symptoms that are moderately severe for at least 6 months despite treatment.Your liver function tests are more than twice the normal limit in the 30 days before the study.You have taken part in a gene transfer study before.I have a diagnosed liver condition.I have not had a major heart attack in the last 6 months.I have not had a fever or positive infection test in the last 48 hours.My platelet count is above 50,000.
Research Study Groups:
This trial has the following groups:- Group 1: 3 x 10e13vg NAN-101
- Group 2: 1 x 10e14vg NAN-101
- Group 3: 3 x 10e14 vg NAN-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaged in this medical exploration?
"Affirmative. Clinicaltrials.gov indicates that this experiment is actively recruiting individuals, which was initially announced on November 20th 2019 and subsequently updated on June 3rd 2021. The research necessitates 12 volunteers from 3 separate facilities."
Answered by AI
Is enrollment still open for participants in this experiment?
"According to the records on clinicaltrials.gov, this medical research initiative is presently seeking volunteers. The trial was first published in November of 2019 and most recently revised in June 2021."
Answered by AI
Has the FDA verified 3 x 10e13vg NAN-101 as safe and effective?
"With only limited data showcasing its safety and efficacy, 3 x 10e13vg NAN-101 received a score of 1."
Answered by AI
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