hCT-MSC / Duke University - LARVOL DELTA

Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "Here we aimed to identify the safety and efficacy of cell injections from autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells, in comparison to corticosteroid injection (CSI)...In summary, this study shows that at 1 year post injection, there was no superior orthobiologic as compared to CSI for knee osteoarthritis. ClinicalTrials.gov Identifier: NCT03818737."

Clinical • Journal • P3 data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Pilot Phase I Trial of Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells in Neonates With Hypoxic-Ischemic Encephalopathy. (PubMed, Stem Cells Transl Med) - "Allogeneic cord tissue mesenchymal stromal cells (hCT-MSC), cryopreserved and readily available, have been shown to ameliorate brain injury in animal models of HIE...All babies survived, with average to low-average developmental assessment standard scores for ages between 12 and 17 postnatal months. Further study is warranted."

Journal • P1 data • Stroma • CNS Disorders • Vascular Neurology

Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome. (PubMed, Stem Cells Transl Med) - "We were able to collect relevant safety outcomes for the use of hCT-MSCs in patients with COVID-19-related ARDS. Future studies to explore their safety and efficacy are warranted."

Journal • Stroma • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

TACT: Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Duke University | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Aug 2022 | Trial primary completion date: Dec 2022 ➔ Aug 2022

Stroma • Trial completion • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Motor function and safety after allogeneic cord blood and cord tissue-derived mesenchymal stromal cells in cerebral palsy: An open-label, randomized trial. (PubMed, Dev Med Child Neurol) - "High-dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo-controlled trial."

Journal • Cardiovascular • Cerebral Palsy • CNS Disorders

A Phase I Study of Allogeneic Umbilical Cord Tissue Derived Mesencymal Stromal Cells for Term and Near Term Infants with Hypoxic-Ischemic Encephalopathy (HIE) (TCT-ASTCT-CIBMTR 2022) - "Our results suggest that hCT-MSC, an umbilical cord tissue-derived MSC product, can be prepared and infused safely in infants treated with hypothermia for moderate - severe HIE. Further safety and efficacy studies are warranted."

P1 data • CNS Disorders • Infectious Disease • Vascular Neurology

TACT: Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Duke University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Autism Spectrum Disorder • Genetic Disorders

TACT: Open Label Phase I hCT-MSC in Toddlers With Autism Spectrum Disorder (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Duke University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Autism Spectrum Disorder • Genetic Disorders

[VIRTUAL] A Randomized Trial Comparing Umbilical Cord Blood and Cord Tissue Mesenchymal Stromal Cells in Young Children with Cerebral Palsy (TCT-ASTCT-CIBMTR 2021) - "Objectives: To describe change in gross motor function in young children with CP after treatment with allogeneic unrelated donor CB or allogeneic, third party, human cord tissue-derived MSC (hCT-MSC) 12 months post treatment... High dose allogeneic CB infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect seen in a prior study of autologous CB. An increase of 3.3 points on the GMFM-66 exceeds minimum clinically important differences of large effect sizes, and as such is clinically relevant. A phase 3 randomized placebo controlled study should be performed to confirm this observation."

Clinical • Cardiovascular • Cerebral Palsy • CNS Disorders • Vascular Neurology

[VIRTUAL] A Randomized Trial Comparing Umbilical Cord Blood and Cord Tissue Mesenchymal Stromal Cells in Young Children with Cerebral Palsy (TCT-ASTCT-CIBMTR 2021) - "Objectives: To describe change in gross motor function in young children with CP after treatment with allogeneic unrelated donor CB or allogeneic, third party, human cord tissue-derived MSC (hCT-MSC) 12 months post treatment... High dose allogeneic CB infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect seen in a prior study of autologous CB. An increase of 3.3 points on the GMFM-66 exceeds minimum clinically important differences of large effect sizes, and as such is clinically relevant. A phase 3 randomized placebo controlled study should be performed to confirm this observation."

Clinical • Cardiovascular • Cerebral Palsy • CNS Disorders • Vascular Neurology

[VIRTUAL] A Randomized Trial Comparing Umbilical Cord Blood and Cord Tissue Mesenchymal Stromal Cells in Young Children with Cerebral Palsy (TCT-ASTCT-CIBMTR 2021) - "Objectives: To describe change in gross motor function in young children with CP after treatment with allogeneic unrelated donor CB or allogeneic, third party, human cord tissue-derived MSC (hCT-MSC) 12 months post treatment... High dose allogeneic CB infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect seen in a prior study of autologous CB. An increase of 3.3 points on the GMFM-66 exceeds minimum clinically important differences of large effect sizes, and as such is clinically relevant. A phase 3 randomized placebo controlled study should be performed to confirm this observation."

Clinical • Cardiovascular • Cerebral Palsy • CNS Disorders • Vascular Neurology

[VIRTUAL] A Randomized Trial Comparing Umbilical Cord Blood and Cord Tissue Mesenchymal Stromal Cells in Young Children with Cerebral Palsy (TCT-ASTCT-CIBMTR 2021) - "Objectives: To describe change in gross motor function in young children with CP after treatment with allogeneic unrelated donor CB or allogeneic, third party, human cord tissue-derived MSC (hCT-MSC) 12 months post treatment... High dose allogeneic CB infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect seen in a prior study of autologous CB. An increase of 3.3 points on the GMFM-66 exceeds minimum clinically important differences of large effect sizes, and as such is clinically relevant. A phase 3 randomized placebo controlled study should be performed to confirm this observation."

Clinical • Cardiovascular • Cerebral Palsy • CNS Disorders • Vascular Neurology

[VIRTUAL] A Randomized Trial Comparing Umbilical Cord Blood and Cord Tissue Mesenchymal Stromal Cells in Young Children with Cerebral Palsy (TCT-ASTCT-CIBMTR 2021) - "Objectives: To describe change in gross motor function in young children with CP after treatment with allogeneic unrelated donor CB or allogeneic, third party, human cord tissue-derived MSC (hCT-MSC) 12 months post treatment... High dose allogeneic CB infusion is associated with gross motor improvement in young children with CP, consistent with the dose effect seen in a prior study of autologous CB. An increase of 3.3 points on the GMFM-66 exceeds minimum clinically important differences of large effect sizes, and as such is clinically relevant. A phase 3 randomized placebo controlled study should be performed to confirm this observation."

Clinical • Cardiovascular • Cerebral Palsy • CNS Disorders • Vascular Neurology