Perianal FistulaPhase 1/2NCT05836883
Study of ExoFlo for the Treatment of Perianal Fistulas
A Phase 1/2 study testing ExoFlo and Local injection of normal saline in people with Perianal Fistula and Crohn's Disease, run by Direct Biologics, LLC at 1 site in United States.
Trial summary
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perianal Fistula, Crohn's Disease
- What is being tested?
- ExoFlo and Local injection of normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 1 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women 18-75 years of age with a diagnosis of Crohn's Disease (CD) for at least six months duration.
- Single and/or Multi-tract Perianal fistula(s).
- Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (infliximab, adalimumab, certolizumab, ustekinumab, golimumab, vedolizumab), or small molecule inhibitors.
- Previous failed surgical intervention, including seton placement at least two weeks prior, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula.
- Medical therapy for CD stable for at least 2 months prior to administration of IMP. Changes in dosing or dosing intervals related to serum drug levels are permitted.
- Ability to comply with protocol.
- Competent and able to provide written informed consent.
Who cannot join
- Active perianal abscess or infection at the time of screening, enrollment, or at the time of investigational product administration
- Clinically significant medical conditions within the six months before administration of IMP that would, in the opinion of the investigators, compromise the safety of the subject.
- History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
- History of colorectal cancer within 2 years
- Subjects who have a diagnosis of coagulation disorders and/or are currently on anti-coagulant therapy
- Investigational drug within one month of treatment
Show all 20Show fewer
- Pregnant or breast feeding or trying to become pregnant.
- Presence of a rectovaginal fistula
- Presence of an ileal anal pouch and/or history of proctectomy
- The presence of severe proctitis
- Any condition which, in the opinion of the investigator, would make it unsafe or unsuitable for patients to undergo Magnetic Resonance (MR) evaluations (i.e., presence of implantable or external MR unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia etc.).
- A participant who is unwilling to use medically acceptable contraception methods during participation in study
- The following out of range laboratory results at screening (result may be repeated)
- WBC >11 x 109 /L
- Hemoglobin < 8 g/dl
- Platelet count <100,000/mL
- AST/ALT >2 times the upper limit of normal
- Creatinine >2 umol/L
- PT/INR: outside normal limits
- Hemoglobin A1c>6.5 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Direct Biologics Investigational Site
Los Angeles, California, 90048
About this study
Official title: A Phase IB/IIA Study of ExoFlo, an Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Perianal Fistulizing Crohn's Disease
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
Read the detailed description
This is a phase IB/IIA, multicenter, single-blind, placebo-controlled, dose-escalation design, randomized controlled trial for the treatment of Perianal Fistulizing Crohn's Disease.
Subjects will be randomized 2:1 Investigational Medicinal Product (IMP) to normal saline (NS) in cohorts of 12 subjects as follows:
Cohort 1: Local injection of 15 mL of IMP or NS on Day 0 (8 IMP, 4 NS)
- Conditions
- Perianal Fistula, Crohn's Disease
- Being tested
- ExoFlo, Local injection of normal saline
- Keywords
- Perianal Fistula, Perianal Fistulizing Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoFloBiological
Local injection of bone marrow mesenchymal stem cell derived extracellular vesicles
Local injection of normal salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Local injection 15 mL of normal saline on Day 0 Receives: Other: Local injection of normal saline |
| Cohort 1: Treatment | Experimental | Local injection of 15 mL of ExoFlo on Day 0 Receives: Biological: ExoFlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start28 Aug 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Why it stopped: Enrollment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multicenter, Placebo-controlled, Dose-escalation Design, Randomized Controlled Trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direct Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bill Arana, Study director, Direct Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836883
- Sponsor's protocol ID
- DB-EF-PFCD-1a
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2023
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/IIA Study of ExoFlo, an Ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Perianal Fistulizing Crohn's Disease
- ClinicalTrials.gov ID
- NCT05836883
- Acronym / sponsor ID
- DB-EF-PFCD-1a
- Conditions
- Perianal Fistula, Crohn's Disease
- Keywords
- Perianal Fistula, Perianal Fistulizing Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Direct Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
Detailed description
This is a phase IB/IIA, multicenter, single-blind, placebo-controlled, dose-escalation design, randomized controlled trial for the treatment of Perianal Fistulizing Crohn's Disease.
Subjects will be randomized 2:1 Investigational Medicinal Product (IMP) to normal saline (NS) in cohorts of 12 subjects as follows:
Cohort 1: Local injection of 15 mL of IMP or NS on Day 0 (8 IMP, 4 NS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter, Placebo-controlled, Dose-escalation Design, Randomized Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Other: Local injection of normal salineLocal injection 15 mL of normal saline on Day 0 |
| Cohort 1: Treatment | Experimental | Biological: ExoFloLocal injection of 15 mL of ExoFlo on Day 0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and Women 18-75 years of age with a diagnosis of Crohn's Disease (CD) for at least six months duration.
- Single and/or Multi-tract Perianal fistula(s).
- Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (infliximab, adalimumab, certolizumab, ustekinumab, golimumab, vedolizumab), or small molecule inhibitors.
- Previous failed surgical intervention, including seton placement at least two weeks prior, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula.
- Medical therapy for CD stable for at least 2 months prior to administration of IMP. Changes in dosing or dosing intervals related to serum drug levels are permitted.
Key exclusion criteria (20 listed)
- Active perianal abscess or infection at the time of screening, enrollment, or at the time of investigational product administration
- Clinically significant medical conditions within the six months before administration of IMP that would, in the opinion of the investigators, compromise the safety of the subject.
- History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
- History of colorectal cancer within 2 years
- Subjects who have a diagnosis of coagulation disorders and/or are currently on anti-coagulant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExoFloLocal injection of bone marrow mesenchymal stem cell derived extracellular vesicles | Biological | Cohort 1: Treatment |
| Local injection of normal salinePlacebo | Other | Cohort 1: Placebo |
Primary outcome
Adverse Events
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Direct Biologics, LLCLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Arana study director
Direct Biologics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ExoFlo and Local injection of normal saline in people with Perianal Fistula and Crohn's Disease, run by Direct Biologics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.