Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05176366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2021-11-17
Brief Title:
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
A Phase I Study of ExoFlo an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product for the Treatment of Medically Refractory Ulcerative Colitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Protocol Summary
Title A Phase I study of ExoFlo an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product for the treatment of medically refractory ulcerative colitis
Short Title ExoFlo for ulcerative colitis
Phase 1
Methodology Open label
Study Duration 24 months
Subject Participation 58 weeks
Single or Multi-Site Multi-Site
Title A Phase I study of ExoFlo an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product for the treatment of medically refractory ulcerative colitis
Short Title ExoFlo for ulcerative colitis
Phase 1
Methodology Open label
Study Duration 24 months
Subject Participation 58 weeks
Single or Multi-Site Multi-Site
Detailed Description:
Primary Objectives
To evaluate the feasibility of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the safety of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
Secondary Objectives
To evaluate the efficacy of intravenous ExoFlo in inducing clinical remission in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the efficacy of intravenous ExoFlo in inducing clinical response in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the efficacy of intravenous ExoFlo in improving disease-specific health-related quality of life
To evaluate the pharmacokinetics and pharmacodynamics of ExoFlo therapy including changes in C-reactive protein CRP and fecal calprotectin
Number of Subjects 10
Diagnosis and Main Inclusion Criteria Subjects must have medically refractory ulcerative colitis and have no prior intestinal surgery for ulcerative colitis
Study Product Dose Route Regimen
IV administration of 15 mL of study agent at Day 0 Day 2 Day 4 and 30 mL at Week 2 Week 6 and every 4 weeks thereafter to week 46 n10 total doses 15
Statistical Methodology This is a safety study with exploratory assessment of efficacy The study has insufficient power to confirm efficacy All assessments of efficacy will be exploratory for the purpose of hypothesis generation in larger sample sizes
To evaluate the feasibility of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the safety of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
Secondary Objectives
To evaluate the efficacy of intravenous ExoFlo in inducing clinical remission in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the efficacy of intravenous ExoFlo in inducing clinical response in subjects with medically refractory ulcerative colitis who have failed or are intolerant or have a contraindication to one or more monoclonal antibodies
To evaluate the efficacy of intravenous ExoFlo in improving disease-specific health-related quality of life
To evaluate the pharmacokinetics and pharmacodynamics of ExoFlo therapy including changes in C-reactive protein CRP and fecal calprotectin
Number of Subjects 10
Diagnosis and Main Inclusion Criteria Subjects must have medically refractory ulcerative colitis and have no prior intestinal surgery for ulcerative colitis
Study Product Dose Route Regimen
IV administration of 15 mL of study agent at Day 0 Day 2 Day 4 and 30 mL at Week 2 Week 6 and every 4 weeks thereafter to week 46 n10 total doses 15
Statistical Methodology This is a safety study with exploratory assessment of efficacy The study has insufficient power to confirm efficacy All assessments of efficacy will be exploratory for the purpose of hypothesis generation in larger sample sizes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None