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E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas

ConditionAnal Fistula
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

The purpose of this study is to determine if endothelial cells derived from human umbilical vein are safe for use in conjunction with fistulotomy for the treatment of simple anal fistulas. Endothelial cells are a special kind of cell in the body that line the inside surface of blood vessels. The goal of the study is to evaluate the preliminary safety of human umbilical vein cells in anal fistula healing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject ages 18 or older

Subject willing and able to provide informed consent

Subject is medically eligible and have agreed to undergo a fistulotomy

Subject with simple perianal fistula with 2 or fewer fistula tracts

Disqualifiers

Concomitant rectovaginal fistulas

Subjects with an abscess

Presence of active infections findings (e.g.; redness, swelling, tenderness or fever)

Presence of rectal and/or anal stenosis

Trial design

Design model

Sequential

Treatments tested in this trial

  • E-CEL UVEC

    Drug

    Injection of E-CEL UVEC

Treatment groups

39 Participants
are divided into 5 treatment groups
Group A: Cell Therapy TreatmentExperimental treatment 1 intervention
Group B: Cell Therapy Treatment Part BS1Experimental treatment 1 intervention
Group C: Cell Therapy Treatment Part BS2Experimental treatment 1 intervention
Group D: Cell Therapy Treatment Part BM1Experimental treatment 1 intervention
Group E: Cell Therapy Treatment Part BM2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of dose escalation, as measured by incidence rate of treatment emergent adverse events following the administration of E-CEL UVEC

The short term safety of escalating dose of E-CEL UVEC cells in subjects with anal fistulas will be assessed by monitoring and recording all adverse events for 2 weeks following the administration of E-CEL UVEC. (Applicable to all arms)

Time frame
2 weeks

Secondary outcomes

1

Efficacy of E-CEL UVEC, as measured the rate of subjects presenting with relapse in treated fistula

Efficacy of E-CEL UVEC, as measured the rate of subjects presenting with relapse in treated fistula at week 6 and 24 (Applicable to all arms)

Time frame
6, 24 weeks after surgery
2

E-CEL UVEC Treatment Success, as measured by the combination of cessation and absence of fistula leakage

The success of E-CEL UVEC cells in subjects with anal fistulas will be assessed via digital pressure after completion of all treatments. (Applicable to all arms)

Time frame
24 weeks after surgery
3

Efficacy of E-CEL UVEC, as measured by time to complete healing of each side

Efficacy of E-CEL UVEC, as measured by time to complete healing of each side of injection site (Applicable to all arms)

Time frame
24 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Angiocrine Bioscience

Collaborator

Source ClinicalTrials.gov
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