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Tolerogenic Fibroblasts

Phase 1

Multiple Sclerosis, Relapsing-Remitting | Monoclonal antibody | Immunology |FibroBiologics, Inc.|Last Updated: Oct 22, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05080270Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple SclerosisEARLY_PHASE1 COMPLETED 5Sep 21, 2020Jun 8, 2021Oct 22, 20211 Mexico
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Study Endpoints
Primary Endpoints
Safety: Adverse even monitoring of subjects for 4 hours after infusion
Monitoring during the Intravenous infusion of allogeneic tolerogenic fibroblasts, and continued for 4 hours after infusion

Monitor subjects for possible treatment-related acute immune symptoms or vascular occlusion symptoms during the administration of the allogeneic tolerogenic fibroblasts via intravenous infusion.

Safety: Complete Blood Count to monitor inflammation markers
Day before infusion to establish a baseline, week 8, and week 16 after infusion

Complete Blood Count used to monitor inflammation markers included white blood cell (WBC), neutrophil (N), lymphocyte (L), neutrophil-lymphocyte ratio (NLR), mean platelet volume (MPV), and platelet-lymphocyte ratio. This safety test is to monitor subjects for inflammation during the course of the study, relating to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion

Safety: Serum chemistry to monitor impact on serum chemistry
Day before infusion to establish a baseline, week 8, and week 16 after infusion

This test will measure the amount of certain substances in serum samples, including electrolytes (such as sodium, potassium, and chloride), fats, proteins, glucose (sugar), and enzymes. Blood chemistry tests give essential information about how well a person's kidneys, liver, and other organs are working. An abnormal amount of a substance in the blood can be a sign of disease or a side effect of treatment. Blood chemistry tests help diagnose and monitor many conditions before, during, and after treatment. Also called blood chemistry study.

Safety: 12-lead Electrocardiogram (ECG) to monitor cardiovascular health
Day before infusion to establish a baseline, week 8, and week 16 after infusion

A 12-lead electrocardiogram will be used to monitor the baseline cardiovascular health of the participants and continue to monitor their cardiovascular health during the course of the study measuring heart rate, blood pressure, ventricular rate, PR interval, RP interval, QRS interval, and GT interval. This safety test is to monitor the subjects for cardiac events related to the course of the disease, or allogeneic tolerogenic fibroblasts administered through Intravenous infusion

Secondary Endpoints
Efficacy: Expanded Disability Status Scale (EDSS) to quantify disability scale and monitors changes
Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Paced Auditory Serial Addition Test (PASAT) to measure cognitive function and processing speed
Day before infusion to establish a baseline, week 8, and week 16 after infusion
Efficacy: Nine-Hole Peg Test to measure and quantify upper extermity function
Day before infusion to establish a baseline, week 8, and week 16 after infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
tolerogenic fibroblasts administered via intravenous infusionEXPERIMENTALA single dose of 100 million tolerogenic fibroblasts administered via intravenous infusion.
Interventions
NameTypeDescription
Tolerogenic FibroblastsBIOLOGICALadministrating single dose of 100 million tolerogenic fibroblasts via intravenous infusion
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients willing to sign an informed consent and capable of understanding the features of this clinical trial. 2. Willing to keep a weekly diary and undergo observation for four months 3. Non-pregnant patients 18-55 years of age with MS according to the revised McDonald crite...

Countries:Mexico
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