All > Anal Fistula

E-CEL UVEC for Anal Fistulas

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weill Cornell Medical College - NewYork-Presbyterian Hospital, New York, NYAnal FistulasE-CEL UVEC - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether it's safe to use human umbilical vein cells to help heal anal fistulas.

Eligible Conditions
  • Anal Fistulas

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6, 24 weeks after surgery

2 weeks
Safety of dose escalation, as measured by incidence rate of treatment emergent adverse events following the administration of E-CEL UVEC
24 weeks
Long-Term Safety of E-CEL UVEC, as measured by the number of adverse events for 24 weeks following the administration of E-CEL UVEC
24 weeks after surgery
Efficacy of E-CEL UVEC, as measured by time to complete healing of each side
6 weeks
Long-Term Safety of E-CEL UVEC, as measured by the number of adverse events at 6 weeks following the administration of E-CEL UVEC
Week 24
Efficacy of E-CEL UVEC, as measured the rate of subjects presenting with relapse in treated fistula

Trial Safety

Safety Progress

1 of 3

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1
MSC-AFP
1
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1
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Trial Design

2 Treatment Groups

Cell Therapy Treatment Part B
1 of 2
Cell Therapy Treatment
1 of 2

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: E-CEL UVEC · No Placebo Group · Phase 1

Cell Therapy Treatment Part B
Drug
Experimental Group · 1 Intervention: E-CEL UVEC · Intervention Types: Drug
Cell Therapy Treatment
Drug
Experimental Group · 1 Intervention: E-CEL UVEC · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 24 weeks after surgery

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
997 Previous Clinical Trials
1,341,943 Total Patients Enrolled
Angiocrine BioscienceIndustry Sponsor
4 Previous Clinical Trials
220 Total Patients Enrolled
Jeffrey W Milsom, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The maximum length allowed for a medical device or tool that will be inserted into your body is 3 inches.
References

Frequently Asked Questions

To what extent is this study populated with participants?

"Affirmative, based on the information hosted by clinicaltrials.gov this medical study is currently recruiting. It was originally published on January 22nd 2020 and most recently edited April 29th 2022. They are looking for 12 individuals to enroll in their experiment at one centre." - Anonymous Online Contributor

Unverified Answer

What implications does E-CEL UVEC pose for the health of individuals?

"Our team at Power assessed E-CEL UVEC's safety as a 1 due to the limited data on both its efficacy and security, characteristic of Phase 1 trials." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this research project still open?

"According to clinicialtrials.gov, this research is actively recruiting for new participants as of 4/29/2022. It was initially posted on 1/22/2020." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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