News | Stem Cell Therapies | March 04, 2019

FDA Releases Final Guidances on Regenerative Medicine Therapies

Viable cardiac tissue regeneration could greatly reduce burden of heart failure

FDA Releases Final Guidances on Regenerative Medicine Therapies

March 4, 2019 — The U.S. Food and Drug Administration (FDA) recently finalized two guidance documents regarding regenerative medicine therapies. In the cardiology arena, there are ongoing research efforts and several clinical trials looking at the use of stem cells to repair myocardial infarcts following heart attacks. If cardiac tissue regeneration became viable, it holds the promise of greatly reducing heart failure, which is a major cost driver in the U.S. healthcare system.

Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.

The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies, which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

Read the first final guidance here.

The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation and Accelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.

Read the second final guidance here.

For more information: www.fda.gov

Related Content

Max and Debra Ernst Heart Center Opening at Beaumont Hospital, Royal Oak
News | Heart Failure | September 20, 2019
The new Max and Debra Ernst Heart Center at Beaumont Hospital, Royal Oak, Mich., will open Sept. 30. It is dedicated to...
FDA Grants Fast Track Designation for Farxiga in Heart Failure
News | Heart Failure | September 18, 2019
AstraZeneca announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the...
Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Device Clinical Trial

The REDUCE LAP HF-II study will combine Corvia Medical's InterAtrial Shunt Device (IASD), pictured here, with physIQ's continuous monitoring platform to evaluate the device's efficacy in patients with heart failure. Image courtesy of Corvia Medical.

News | Heart Failure | September 12, 2019
Corvia Medical has sponsored and is actively enrolling patients in a heart failure (HF) device trial that, in addition...
 Tiny Wearable Cameras May Improve Quality of Life in Heart Failure Patients

Image courtesy of Amazon.com

News | Heart Failure | September 11, 2019
The ever-present devices that seem to track all our moves can be annoying, intrusive or worse, but for heart failure...
PARAGON-HF Misses Endpoint in Preserved Heart Failure
News | Heart Failure | September 11, 2019
The angiotensin neprilysin inhibitor sacubitril/valsartan (Entresto) missed its primary endpoint of reducing total...
Farxiga Significantly Reduces Cardiovascular Death and Worsening of Heart Failure
News | Heart Failure | September 09, 2019
AstraZeneca announced detailed results from the landmark Phase III DAPA-HF trial that showed Farxiga (dapagliflozin) on...
Dapagliflozin, Forxiga, was found to help improve outcomes in heart failure patients with reduced ejection fraction (HFrEF) at ESC 2019. #ESC19 #ESC2019
News | Heart Failure | September 09, 2019
September 9, 2019 — The drug Dapagliflozin was found to reduce death and hospitalization in patients who have heart f
Entresto Improved Measures of Heart Structure and Function in Heart Failure Patients
News | Heart Failure | September 04, 2019
September 4, 2019 – Novartis announced results from two new...
FDA Approves Barostim Neo System for Advanced Heart Failure Patients. Similar to a pacemaker, the Barostim Neo System uses a pulse generator implanted below the collar bone with a lead that attaches to the carotid artery in the neck. It delivers electrical impulses to baroreceptors in the neck, which sense how blood is flowing through the carotid arteries and relays information to the brain. The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels.

Similar to a pacemaker, the Barostim Neo System uses a pulse generator implanted below the collar bone with a lead that attaches to the carotid artery in the neck. It delivers electrical impulses to baroreceptors in the neck, which sense how blood is flowing through the carotid arteries and relays information to the brain. The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

Technology | Heart Failure | August 19, 2019
The U.S. Food and Drug Administration (FDA) approved the Barostim Neo System for the improvement of symptoms in...
Ancora Heart Enrolls First Patient in European Multi-center Study of AccuCinch Heart Failure Therapy
News | Heart Failure | August 14, 2019
Ancora Heart Inc. announced the first patient was enrolled in the CorCinch EU study, a European multi-center clinical...
Overlay Init