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

Conditions

• Anal Fistula

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• E-CEL UVEC — DRUG
  Injection of E-CEL UVEC

Study Details

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.

Key Dates

Start date

Jan 22, 2020

Status verified

Nov 2025

Primary completion

Sep 30, 2026

Completion

Jun 30, 2032

Study Design

Enrollment

39 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cell Therapy Treatment
  Patients who present with simple anal fistula and elect to undergo fistulotomy for treatment will be eligible to have E-CEL UVEC injected into the fistula at the time of fistulotomy to aid in healing.
• Experimental: Cell Therapy Treatment Part BS1
  Adult subjects with simple perianal fistula who meet all eligibility criteria to participate in Part B of the study will be treated in the outpatient setting with curettage and E-CEL UVEC cells without fistulotomy. E-CEL UVEC cells will be injected along the two sides (180 degrees apart from each other) of the whole length of the curetted anal fistula tract.
• Experimental: Cell Therapy Treatment Part BS2
  Subjects in Part B2-S will have the same eligibility criteria and would undergo the same procedure as described in Part B1, except that B2-S subjects will also have suturing and injection of the internal opening.
• Experimental: Cell Therapy Treatment Part BM1
  Subjects in Part BM1 will have the same eligibility criteria and would undergo the same procedure as described in Part B1, except that B2-M subjects in this cohort are eligible for up to 4 treatments (versus 1 in Part BS2).
• Experimental: Cell Therapy Treatment Part BM2
  This cohort comprises of multiple (M) treatments with E-CEL UVEC injections. The difference between Part BM1 and Part BM2, is that the subjects in the latter cohort receive double the dose of E-CEL UVEC cells per treatment. Subjects in Part BM2 will have the same eligibility criteria as Part BS1, BS2 and BM1 cohorts and would undergo the same treatment procedure as described in Parts BS1, BS2 and BM1. Every treatment consists of the percutaneous injection along both sides of the fistula tract plus injection of the internal opening via direct anoscopic visualization (described in the next paragraph). Dosing is 30 x 106 viable E-CEL UVEC cells into the area of the internal opening and minimum 30 x 106 viable E-CEL UVEC cells per centimeter along the fistula tract (15x106 viable E-CEL UVEC cells, each side per centimeter of the tract). All subjects in this cohort receive up to 6 treatments over 6 months. The six treatments are administered on visits WK 0, 3. 6, 9, 12 and 24.

Primary Outcome Measure

Safety of dose escalation, as measured by incidence rate of treatment emergent adverse events following the administration of E-CEL UVEC [ Time Frame: 2 weeks ]

Central Contacts

• KM Muktasid
  646-962-2789
  [email protected]
• Ananya Sen
  646-962-6445
  [email protected]

Locations (1)

Find similar trials in New York, NY

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