E-CEL UVEC as an Adjunct Cell Therapy for Treatment of An... | NCT04190862

NCT04190862

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Angiocrine Bioscience	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cell Therapy Treatment	Experimental	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.	Drug: E-CEL UVEC
Cell Therapy Treatment Part BS1	Experimental	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.	Drug: E-CEL UVEC
Cell Therapy Treatment Part BS2	Experimental	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.	Drug: E-CEL UVEC
Cell Therapy Treatment Part BM1	Experimental	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).	Drug: E-CEL UVEC
Cell Therapy Treatment Part BM2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E-CEL UVEC	Drug	Injection of E-CEL UVEC	Cell Therapy Treatment Cell Therapy Treatment Part BM1 Cell Therapy Treatment Part BM2 Cell Therapy Treatment Part BS1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)	6, 24 weeks after surgery
E-CEL UVEC Treatment Success, as measured by the combination of cessation and absence of fistula leakage

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Maximum tract length of 3 inches
Subject without history of Crohn's disease/ Ulcerative Colitis
For female subjects of childbearing potential:
A negative serum or urine pregnancy test at screening is required prior to enrollment
Subject must be willing to use a highly effective method of contraception from the start of the screening period throughout the study period
For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of the conditioning therapy for at least 1 year after completion and discussion with a treating physician

Exclusion Criteria:

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
The presence of setons unless removed prior to the treatment
Subjects with ongoing steroid treatment or treated with steroids in the last 4 weeks
Renal impairment defined by creatinine clearance below 90 mL/min calculated using Cockcroft-Gault formula or by serum creatinine ≥ 1.5 x upper limit of normality (ULN)
Hepatic impairment defined by both of the following laboratory ranges:
Total bilirubin ≥ 1.5 x ULN unless benign congenital hyperbilirubinemia
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.5 x ULN
Known history of abuse of alcohol or other addictive substances in the 6 months prior to enrollment
Active malignant tumor within 5 years
Current recent history of abnormal, severe, progressive, uncontrolled hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases
Congenital or acquired immunodeficiencies including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
Major surgery or severe trauma within the previous 6 months
Subjects who are candidates for solid organ transplantation or who may have a high likelihood of needing a solid organ transplant (ex. progressive heart failure)
Females who are who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment
Subjects who have known hypersensitivity or documented allergy to DMSO
Subjects who do not wish to or cannot comply with study procedures
Subjects currently receiving, or having received any investigational drug within 3 months prior to E-CEL UVEC cell therapy

Name	Role	Phone	Extension	Email
KM Muktasid	Contact	646-962-2789		kmm4010@med.cornell.edu
Ananya Sen	Contact	646-962-6445		ase4003@med.cornell.edu

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases