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Unassigned

New Medicines

HeartCelEnd-stage heart failure in patients with coronary artery congenital malformation - adjunctive therapy in patients requiring coronary artery bypass graft

Information

HeartCel
New molecular entity
Celixir
Not Known

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
None
Dec 21No updates posted to company website or US clinical trials registry. It is unclear whether development is continuing [15,16].
Dec 20iMP cell therapy has been awarded advanced therapeutic medicinal product designation by the EMA [13].
Jun 18Celexir announces FDA has approved their IND for a potentially pivotal PIIb multi-centre trial, involving up to 250 patients in Europe and the US [10].
May 17No further progress; company website indicates that additional trials are planned to start ´early 2017´ [8].
May 16Cell Therapy signs a license agreement with Daiichi Sankyo for exclusive development, regulatory and commercial activities in Japan. The revenue from this agreement will be used to progress its US and EU phase III trials programme [7]
Oct 15Cell Therapy Ltd announces that, following a pre-submission meeting with the EMA it will begin the application process for a conditional marketing authorisation (CMA) for Heartcel in Europe. The filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017 [4].
Oct 15Cell Therapy Ltd state on their website that, in 2014, Heartcel reported unprecedented heart regeneration clinical trial results and is scheduled to launch in 2018 to treat ~400,000 patients worldwide [3].
Feb 15Launch predicted 2016 [2]
Feb 15PII trials completed in October 2014 [1]

Category

Mesodermal progenitor cells used as allogeneic stem cell therapy for cardiac regeneration
The unadjusted prevalence of heart failure is 0.72% of all patients registered with a GP in England (QOF 2014-15) [5]. In studies the prevalence of coronary artery anomalies is reported as 0.6% to 1.3% during coronary angiography or 0.3% at autopsy. Relatively few congenital coronary artery anomalies are symptomatic, but around 20% produce life threatening symptoms [6].
End-stage heart failure in patients with coronary artery congenital malformation - adjunctive therapy in patients requiring coronary artery bypass graft
Intracoronary

Trial or other data

Apr 22PII study (NCT03515291) has been terminated [17].
Dec 20Progress of PII study (NCT03515291) unknown - no update has been made to the US clinical trials registry. Enrolment in another study of iMP in cardiomyopathies was suspended because of the Covid-19 pandemic [13,14].
Jan 20PII study (NCT03515291; 2017-000516-42) is due to start recruiting 50 patients. A previous clinical study found that participants who received injections of immunomodulatory progenitor cells (iMP cells, "Heartcel") showed a reversal of heart muscle scarring when the cells were injected into heart muscle during coronary artery bypass graft (CABG) surgery. However, the previous trial was a small scale study and did not have a control group. The aim of this study is to perform a larger scale investigation with 50 participants compared to the previous trial of 11, and split the 50 participants into two groups - a test group and a control group, so that a direct comparison may be made between the two groups. Collection of primary outcome data (change in left ventricular LGE-CMR imaging (e.g. scar/fibrosis volume reduction), iMP group compared to control group) is due to complete Jan 21 [12].
Dec 19UK trial sites; NCT03515291 (Brompton and Harefield)
May 17Global scientific position paper on cardiovascular regenerative medicine published in the European Heart Journal [9].
Oct 15Heartcel is an allogeneic, ‘off the shelf’ regenerative medicine consisting of CTL’s proprietary immuno-modulatory progenitor cells (iMPs). Heartcel is delivered as a single application during normal bypass surgery. PII has been completed in 11 patients with severe heart failure at risk of incomplete revascularisation due to coronary artery malformation. Expected mortality for this patient group is ~50-70%. After 2 years follow up, all patients are still alive and free from major adverse cardiac events. Heartcel also showed statistically significant and clinically relevant improvements in heart function (Left Ventricular Ejection Fraction), Size of Scar, and Quality of Life [3].