A Phase I First-in-Human Multicenter Randomized Double-Blinded Placebo- Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors with Anthracycline-Induced Cardiomyopathy

Study of Investigational Treatment for Heart Dysfunction in Cancer Survivors

Recruiting
18 years - 79 years
All
Phase N/A
1 Location

Brief description of study.

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).

Detailed description of study

The purpose of this study is to determine the safety of allogeneic MSCs in patients with anthrcycline-induced cardiomyopathy.


Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: cardiomyopathy
  • Age: 18 years - 79 years
  • Gender: All

Inclusion Criteria
Be a cancer survivor with diagnosis of AIC
Have received the initial diagnosis of AIC at least six months earlier and be on stable, optimally-tolerated therapy with beta-blockers, ACE inhibitors/ARBs, and/or aldosterone antagonists for 3 months, unless contraindicated
Have a period of at least two years of clinical cancer-free state* and low likelihood of recurrence (a five-year risk of recurrence estimated at 30% or less), as determined by an oncologist, based on tumor type, response to therapy, and negative metastatic work-up at the time of diagnosis (*exceptions to this are carcinoma in situ or fully resected basal and squamous cell cancer of the skin.)
Be a candidate for cardiac catheterization
Exclusion Criteria
A life expectancy 8.5%)
An underlying autoimmune disorder or current immunosuppressive therapy (e.g., chronic corticosteroid, rheumatologic or immune modulating therapy) or likelihood of use of immunosuppressive therapy during participation in the trial (medications will be considered on a case by case basis)
A contrast allergy that cannot adequately be managed by premedication
Received gene or cell-based therapy from any source within the previous 12 months
Evidence of active systemic infection at time of study product delivery
HIV and/or active HBV or HCV
Coagulopathy (INR > 1.5) not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors)
Presence of LV thrombus
Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions:
manufactured before the year 2000
leads implanted 6 weeks prior to consent
non-transvenous epicardial or abandoned leads
subcutaneous ICDs
leadless pacemakers
any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated
Pacemaker-dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded)
A cardiac resynchronization therapy (CRT) device implanted 3 months prior to consent
Other MRI contraindications (e.g. patient body habitus incompatible with MRI)
An appropriate ICD firing or anti-tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent
Ventricular tachycardia ? 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent
Cognitive or language barriers that prohibit obtaining informed consent or any study elements (interpreter permitted)
Participation (currently or within the previous 30 days) in a cardiac related investigational therapeutic (including stem cell based therapies) or device trial
Pregnancy, lactation, plans to become pregnant in the next 12 months, or is unwilling to use acceptable forms of birth control during study participation 32. Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up

Updated on 19 Feb 2024. Study ID: 1510353290 (SURG-NHLBI-FINET-SENECA)

This study investigates the safety and feasibility of using an investigational treatment involving allogeneic human mesenchymal stem cells (allo-MSCs) for cancer survivors who have heart problems. These heart problems are a result of a condition called anthracycline-induced cardiomyopathy (AIC), which happens when certain cancer treatments affect the heart's ability to pump blood. The goal is to see if the treatment can be safely given to these patients.

Participants in the study will receive the investigational treatment through a procedure called transendocardial injection. This means the treatment is delivered directly into the heart muscle. The study will monitor patients to ensure the procedure is safe and to observe any effects it may have on their heart condition.

  • Who can participate: Participants must be cancer survivors diagnosed with anthracycline-induced cardiomyopathy at least six months ago. They should have been cancer-free for at least two years with a low risk of recurrence. They must also be on stable heart medication and be suitable for cardiac catheterization.
  • Study details: Participants will receive an investigational treatment through a procedure that injects the treatment directly into the heart muscle. They will be monitored for safety and any effects on their heart condition. The study does not involve a placebo.

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact label
Race
Ethnicity
Other language

Default Content Message Here