NestaCell (mesenchymal stem cells) / Cellavita Scientific Research - LARVOL DELTA

Progress and Perspectives in Allogeneic Cell-Based Pulp Regeneration. (PubMed, Int Endod J) - "Despite encouraging preliminary results, significant limitations remain in the establishment of standardised protocols and the development of reliable techniques for longitudinal cell tracking. In future research, optimised delivery systems, immune-evasive cell engineering and rigorous clinical trial designs should be optimised to advance REPs towards predictable, clinically viable therapies."

Journal • Inflammation • Transplantation

A phase I, open-label study of intravenous human dental pulp stem cells (NestaCell®) at two dose levels in patients with Huntington's disease. (PubMed, Stem Cell Res Ther) - P1 | "hDPSCs infusions were well tolerated and exhibited a favourable safety profile, even with prolonged exposure and follow-up. These findings support the continued clinical development and warrant further investigation in more extensive trials to assess therapeutic efficacy in Huntington's disease."

Journal • CNS Disorders • Critical care • Depression • Huntington's Disease • Lung Cancer • Movement Disorders • Oncology • Solid Tumor • CD4 • CD8

Phase II trial of intravenous human dental pulp stem cell therapy for Huntington's disease: a randomized, double-blind, placebo-controlled study. (PubMed, Stem Cell Res Ther) - P2 | "NestaCell® was well tolerated and showed statistically significant improvements in motor and functional outcomes in HD patients. While MRI trends suggest a potential neuroprotective effect, further investigation is warranted. These findings support the advancement to a Phase III trial to confirm efficacy and long-term safety in a larger cohort."

Clinical • Journal • P2 data • CNS Disorders • Huntington's Disease • Inflammation • Movement Disorders

STAR: Efficacy and Safety of NestaCell® in Huntington's Disease (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Azidus Brasil

New P3 trial • Genetic Disorders • Huntington's Disease • Movement Disorders

Advanced cell therapy with low tissue factor loaded product NestaCell® does not confer thrombogenic risk for critically ill COVID-19 heparin-treated patients. (PubMed, Biomed Pharmacother) - "Since the COVID-19 pandemic started, mesenchymal stromal cells (MSC) appeared as a therapeutic option to reduce the over-activated inflammatory response and promote recovery of lung damage. Our COVID-19 clinical study measured and selected the therapeutic cells with low TF (less than 25% of TF+ hIDPSCs). Our data indicate that the concomitant administration of enoxaparin and low TF-loaded is safe even for critically ill COVID-19 patients."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease

HOPE: NestCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia (clinicaltrials.gov) - P1; N=66; Not yet recruiting; Sponsor: Azidus Brasil; N=24 ➔ 66

Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Newly added product (clinicaltrials.gov) - Preclinical, Novel Coronavirus Disease

Pipeline update