Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 8:48 AM
Study NCT ID:
NCT05176366
Status:
TERMINATED
Last Update Posted:
2025-02-11
First Post:
2021-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
Sponsor:
Direct Biologics, LLC
Organization:
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:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment challenges.
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 (n=10), (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 (n=10), (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:
True
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?:
False
Is an FDA AA801 Violation?: