Cellaion 
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 1 Product   0 Diseases   1 Product   3 Trials   52 News 
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  PROLONGSTEM: HepaStem Long-Term Safety Registry (clinicaltrials.gov) -  May 29, 2024   
    P=N/A,  N=44, Terminated, 
    N=22 --> 44 | Trial completion date: Jul 2028 --> May 2024 | Enrolling by invitation --> Terminated | Trial primary completion date: Jul 2028 --> May 2024; Sponsor decision related to product development prioritisation.
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion date, Trial termination:  DHELIVER: Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF) (clinicaltrials.gov) -  May 22, 2024   
    P2,  N=133, Terminated, 
    N=22 --> 44 | Trial completion date: Jul 2028 --> May 2024 | Enrolling by invitation --> Terminated | Trial primary completion date: Jul 2028 --> May 2024; Sponsor decision related to product development prioritisation. Trial completion date: Dec 2024 --> May 2024 | Active, not recruiting --> Terminated; Sponsor decision
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date:  DHELIVER: Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF) (clinicaltrials.gov) -  Feb 15, 2024   
    P2,  N=130, Recruiting, 
    Recruiting --> Active, not recruiting Phase classification: P2b --> P2 | N=363 --> 130 | Trial completion date: Jan 2023 --> Dec 2024 | Trial primary completion date: Jan 2023 --> Jul 2024
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    ACLF course profiles over screening period in the phase IIb DHELIVER study (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1544;    
    Preliminary indicators of efficacy on liver health, metabolic and inflammation markers support further study of HepaStem DHELIVER study is an ongoing Phase IIb RCT double-blinded POC trial that aims to demonstrate the efficacy of HepaStem
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion date, Trial primary completion date:  PROLONGSTEM: HepaStem Long-Term Safety Registry (clinicaltrials.gov) -  Jan 14, 2022   
    P=N/A,  N=22, Enrolling by invitation, 
    DHELIVER study is an ongoing Phase IIb RCT double-blinded POC trial that aims to demonstrate the efficacy of HepaStem Trial completion date: Jul 2023 --> Jul 2028 | Trial primary completion date: Jul 2023 --> Jul 2028
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Promethera Biosci
    P2 data, Journal:  A phase II study of human allogeneic liver-derived progenitor cell therapy for acute-on-chronic liver failure and acute decompensation. (Pubmed Central) -  Jun 29, 2021   
    P2
    Human allogeneic liver-derived progenitor cells (HALPC, HepaStem®; Promethera Biosciences, Mont-Saint-Guibert, Belgium) are an advanced therapy medicinal product that could potentially alleviate systemic inflammation and ameliorate liver function in patients with acute-on-chronic liver failure (ACLF) or acute decompensation of cirrhosis (AD)...Patients with liver cirrhosis may suffer from the rapid onset of organ failure or multiple organ failure associated with a high risk of death in the short term. This clinical study of 24 patients suggests that an advanced therapy based on the intravenous infusion of low doses of human allogeneic liver-derived progenitor cells is safe and supports the next phase of clinical development of this type of therapy.
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial withdrawal:  A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients (clinicaltrials.gov) -  Nov 6, 2020   
    P2,  N=0, Withdrawn, 
    We can conclude that adding this combination of anticoagulants is safe and limits infusion-related thrombogenesis to subclinical signs in most of the patients. Recruiting --> Withdrawn
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion:  Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (clinicaltrials.gov) -  Oct 14, 2020   
    P2,  N=24, Completed, 
    Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2023 --> Feb 2022 Active, not recruiting --> Completed
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Promethera Biosciences
    Clinical, Clinical protocol, Journal:  Clinical Protocol to Prevent Thrombogenic Effect of Liver-Derived Mesenchymal Cells for Cell-Based Therapies. (Pubmed Central) -  May 13, 2020   
    This phenomenon however, could be controlled using either a low, or a high cell dose combined with anticoagulants. In clinical practice, this points to the suitability of a low HHALPC dose infusion to cirrhotic patients, provided that platelet and fibrinogen levels are monitored.
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion, Enrollment change:  CIRRHOTIQUE01: Effect of Liver MSCs in Blood of Patients With Liver Disease. (clinicaltrials.gov) -  Mar 27, 2020   
    P=N/A,  N=9, Completed, 
    In clinical practice, this points to the suitability of a low HHALPC dose infusion to cirrhotic patients, provided that platelet and fibrinogen levels are monitored. Enrolling by invitation --> Completed | N=15 --> 9
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Enrollment closed, Enrollment change:  Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (clinicaltrials.gov) -  Jan 8, 2020   
    P2,  N=24, Active, not recruiting, 
    The clinically significant MELD and bilirubin improvement is considered as an encouraging sign of efficacy. Recruiting --> Active, not recruiting | N=12 --> 24
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion date, Trial primary completion date:  PANASH: Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients (clinicaltrials.gov) -  Jan 6, 2020   
    P1/2,  N=24, Recruiting, 
    Recruiting --> Active, not recruiting | N=12 --> 24 Trial completion date: Mar 2020 --> Jul 2020 | Trial primary completion date: Sep 2019 --> Feb 2020
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion, Trial completion date:  Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001) (clinicaltrials.gov) -  May 28, 2019   
    P=N/A,  N=9, Completed, 
    No bleeding occurred at 0.5 and 1.0 x106 cells/kg doses, which were safe in this AD/ACLF patient population. Active, not recruiting --> Completed | Trial completion date: Oct 2018 --> Feb 2019
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Enrollment open:  PROLONGSTEM: HepaStem Long-Term Safety Registry (clinicaltrials.gov) -  May 28, 2019   
    P=N/A,  N=22, Enrolling by invitation, 
    Active, not recruiting --> Completed | Trial completion date: Oct 2018 --> Feb 2019 Not yet recruiting --> Enrolling by invitation
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion date, Trial primary completion date:  Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (clinicaltrials.gov) -  May 24, 2019   
    P2,  N=12, Recruiting, 
    Not yet recruiting --> Enrolling by invitation Trial completion date: Mar 2018 --> Jun 2020 | Trial primary completion date: Mar 2018 --> Jun 2019
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial completion date:  CIRRHOTIQUE01: Effect of Liver MSCs in Blood of Patients With Liver Disease. (clinicaltrials.gov) -  Apr 4, 2019   
    P=N/A,  N=15, Enrolling by invitation, 
    Trial completion date: Mar 2018 --> Jun 2020 | Trial primary completion date: Mar 2018 --> Jun 2019 Trial completion date: Dec 2018 --> Dec 2019
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Trial primary completion date:  Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (clinicaltrials.gov) -  Dec 2, 2017   
    P2,  N=12, Recruiting, 
    Trial completion date: Dec 2018 --> Dec 2019 Trial primary completion date: Oct 2017 --> Mar 2018
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    New trial:  PROLONGSTEM: HepaStem Long-Term Safety Registry (clinicaltrials.gov) -  Nov 17, 2017   
    P=N/A,  N=22, Not yet recruiting, 
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Enrollment open:  Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF (clinicaltrials.gov) -  Sep 25, 2017   
    P2,  N=12, Recruiting, 
    Trial primary completion date: Oct 2017 --> Mar 2018 Not yet recruiting --> Recruiting
  • ||||||||||  HepaStem (heterologous human adult liver-derived mesenchymal stem cells) / Cellaion
    Enrollment closed, Enrollment change, Trial primary completion date:  Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001) (clinicaltrials.gov) -  Oct 4, 2014   
    P=N/A,  N=9, Active, not recruiting, 
    Initiation date: Nov 2012 --> Mar 2012 | Trial primary completion date: Apr 2014 --> Oct 2014 Recruiting --> Active, not recruiting | N=20 --> 9 | Trial primary completion date: Mar 2017 --> Oct 2018