intracoronary cardiosphere-derived stem cell therapy (CPI-003) / Capricor - LARVOL DELTA

A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas (clinicaltrials.gov) - P1; N=8; Completed; Sponsor: St. Jude Children's Research Hospital; Recruiting ➔ Completed; N=36 ➔ 8; Trial primary completion date: Sep 2020 ➔ Dec 2017

Clinical • Enrollment change • Trial completion • Trial primary completion date • Biosimilar • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology

6-Month Results of ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) Trial: A Randomized, Placebo-Controlled, Double-Blind Study (AHA 2017) - "The ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial evaluated the safety and efficacy of IC allogeneic CDCs (CAP 1002) for post- MI LV dysfunction. Patients with recent MI appear to have more potential benefit than those with chronic MI. Complete trial results will be available in November."

Biomarker • Clinical • Cardiovascular

Cardiac stem cells in patients with ischemic cardiomyopathy: Discovery, translation, and clinical investigation (Curr Atheroscler Rep) - Significant strides have been made by investigators in the study of stem cell therapy for cardiac repair, recently with cardiac-derived progenitor cells including cardiospheres, cardiosphere-derived cells & c-kit positive cardiac stem cells; Article reviews both preclinical studies & P1 clinical trials of these cell types

Review • Cardiovascular • Heart Failure

ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration (ALLSTAR) trial: Rationale & Design. (PubMed) - Cell Transplant - "For Phase 2, the primary efficacy endpoint is relative change from baseline in infarct size at 12 months, as assessed by magnetic resonance imaging. The ALLSTAR trial employs a "seamless" WOVE 1 design which enables continuous enrollment from Phase I to Phase 2 and will evaluate the safety of intracoronary administration of allogeneic CDCs and its efficacy in decreasing infarct size in post-MI patients."

Journal • Acute Coronary Syndrome • Biosimilar • Cardiovascular • Heart Failure • Reperfusion Injury

".@Capricor_News receives rare pediatric disease designation from @US_FDA 4 CAP-1002 for Duchenne #musculardystrophy. https://t.co/QH213YanwD" (@CIRMnews)

Clinical • Biosimilar

Capricor announces FDA approval to initiate ALLSTAR trial of allogeneic stem cell therapy in patients following heart attack (Businesswire) - P1, N=31; NCT00893360; Data showed approximately 50% reduction of scar size & 50% more viable muscle in the infarction zones of pts studied one year after a MI; FDA has approved initiation of its IND application for the ALLSTAR study, which will use allogeneic CDCs to treat pts following large MI; ALLSTAR will study the use of CAP-1002 delivered directly into a CA from 30 days to 1 year following a MI; The trial is planned as a 260 patient, 20 center RCT

Anticipated new P2 trial • IND • P1 data • Cardiovascular • Heart Failure

Administration of cardiac stem cells in patients with ischemic cardiomyopathy: The SCIPIO trial (Circulation) - P1, N=33; SCIPIO; Isolation of CSCs from cardiac tissue obtained in the operating room is feasible & does not alter practices during CABG surgery; CMR shows that CSC infusion produces a striking improvement in both global & regional LV function, a reduction in infarct size & an increase in viable tissue that persist at least 1 year & are consistent with cardiac regeneration

P1 data • Heart Failure

New SNP Markers to Identify Culex Complex Species (Diptera: Culicidae) by High-Resolution DNA Melting Analysis. (PubMed, J Med Entomol) - "Our method provides a high confidence for biotype determination among the three Cx. pipiens complex mosquitoes.Data deposition: NCBI SNP Database (ssSNP accession nos.: ss947848635-ss947848878)."

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