Trial Outcomes & Findings for Study of ExoFlo for the Treatment of Perianal Fistulas (NCT NCT05836883)

Last Updated: 2026-08-11

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

3 Months

Results posted on

2026-08-11

The study was terminated prior to the enrollment of any other cohorts.

Participant milestones
Measure	Cohort 1: Placebo Local injection 15 mL of normal saline on Day 0	Cohort 1: Treatment Local injection of 15 mL of ExoFlo on Day 0
Overall Study STARTED	1	4
Overall Study COMPLETED	1	4
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Study of ExoFlo for the Treatment of Perianal Fistulas

Baseline characteristics by cohort
Measure	Cohort 1: Placebo n=1 Participants Local injection 15 mL of normal saline on Day 0	Cohort 1: Treatment n=4 Participants Local injection of 15 mL of ExoFlo on Day 0	Total n=5 Participants Total of all reporting groups
Age, Continuous	35 years n=54 Participants	35 years n=54 Participants	35 years n=27 Participants
Sex: Female, Male Female	0 Participants n=54 Participants	2 Participants n=54 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=54 Participants	2 Participants n=54 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	1 Participants n=54 Participants	2 Participants n=54 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	0 Participants n=54 Participants	1 Participants n=54 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	0 Participants n=54 Participants	1 Participants n=54 Participants	1 Participants n=27 Participants
Region of Enrollment United States	1 Participants n=54 Participants	4 Participants n=54 Participants	5 Participants n=27 Participants

Timeframe: 3 Months

Outcome measures
Measure	Cohort 1: Placebo n=1 Participants Local injection 15 mL of normal saline on Day 0	Cohort 1: Treatment n=4 Participants Local injection of 15 mL of ExoFlo on Day 0
Adverse Events	1 Participants	3 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Cohort 1: Placebo n=1 participants at risk Local injection 15 mL of normal saline on Day 0	Cohort 1: Treatment n=4 participants at risk Local injection of 15 mL of ExoFlo on Day 0
General disorders Perianal Pain	100.0% 1/1 • Number of events 1 • 3 Months Treatment Emergent Adverse Events	75.0% 3/4 • Number of events 3 • 3 Months Treatment Emergent Adverse Events
Gastrointestinal disorders Perianal abscess	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events
Gastrointestinal disorders Perianal bleeding	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events
Infections and infestations Yeast infection	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events
Infections and infestations bacterial vaginosis	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events
Renal and urinary disorders Ureaplasma	0.00% 0/1 • 3 Months Treatment Emergent Adverse Events	25.0% 1/4 • 3 Months Treatment Emergent Adverse Events

Direct Biologics

Phone: 5123547124

Restriction type: GT60