Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers — CELLULA

Sepsis Clinical Trial

Official title:
Phase I, Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers

Status Completed

Clinical Trial Summary

Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.

The treatment administration will be infused intravenously to the following groups after randomization:

- First arm: 250,000 cells/kg

- Second arm: 1 million cells/kg

- Third arm: 4 million cells/kg

- Fourth arm: placebo according to their weight.

An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.

Clinical Trial Description

Medicinal product Suspension of expanded adipose-derived allogeneic adult stem cells (eASCs) at a single dose of 250,000 cells/kg, 1 million cells/kg or 4 million cells/kg by intravenous infusion after suspension in Ringer's lactate solution.

Control Placebo (Ringer's lactate solution) Objectives To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.

Design Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.

The treatment administration will be infused intravenously to the following groups after randomization:

- First arm: 250,000 cells/kg

- Second arm: 1 million cells/kg

- Third arm: 4 million cells/kg

- Fourth arm: placebo according to their weight.

An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Sepsis

Clinical Trial Details

NCT number	NCT02328612
Study type	Interventional
Source	Cellerix
Contact
Status	Completed
Phase	Phase 1
Start date	October 2014
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05095324` - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed	`NCT02714595` - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens	Phase 3
Completed	`NCT03644030` - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed	`NCT02867267` - The Efficacy and Safety of Ta1 for Sepsis	Phase 3
Completed	`NCT04804306` - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting	`NCT05578196` - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.	N/A
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT03550794` - Thiamine as a Renal Protective Agent in Septic Shock	Phase 2
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Completed	`NCT03258684` - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock	N/A
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed	`NCT05018546` - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery	N/A
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Not yet recruiting	`NCT05361135` - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.