E-CEL UVEC Cells for Anal Fissures

Recruiting at 1 trial location

Overseen By Jordan Augsburger

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Weill Medical College of Cornell University

Must not be taking: Systemic chemotherapy, Local pelvic radiation

Disqualifiers: Inflammatory bowel diseases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called E-CEL UVEC cells, injected directly into anal fissures. The goal is to determine if this treatment is safe and effective in healing the fissures. It targets individuals with a chronic anal fissure lasting at least six weeks, who have not responded to other treatments, and who experience significant pain during bowel movements. Participants will receive injections and contribute to researchers' understanding of this potential new therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking systemic chemotherapy or local pelvic radiation treatments, you would not be eligible to participate.

Is there any evidence suggesting that E-CEL UVEC cells are likely to be safe for humans?

Research shows that E-CEL UVEC cells are being tested for safety and effectiveness in healing anal fissures. Although clear data from earlier studies is not yet available, the treatment's presence in an early phase trial ensures close monitoring for any risks. The primary goal is to confirm the safety of E-CEL UVEC cells for people. Participants will receive direct injections of these cells into the anal fissure to assess their healing potential. Safety remains a top priority, and any side effects will be carefully documented to evaluate how well participants tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for anal fissures, which often include topical creams, dietary changes, or even surgery, E-CEL UVEC cells offer a novel approach by using a local percutaneous injection of lab-grown cells. These cells aim to promote healing by potentially regenerating the damaged tissue around the fissure. Researchers are excited about this treatment because it represents a biological solution that might address the root cause of the condition, rather than just managing symptoms. This innovative method could lead to quicker recovery and less recurrence, offering a promising alternative for patients who haven't found relief with existing options.

What evidence suggests that E-CEL UVEC cells might be an effective treatment for anal fissures?

Research has shown that E-CEL UVEC cells have been promising in animal studies, helping wounds heal faster and more effectively. In this trial, participants will receive a local percutaneous injection of E-CEL UVEC cells around the anal fissure to evaluate their effectiveness in treating anal fissures. Although human data remains limited, early results suggest that E-CEL UVEC cells might aid in healing anal fissures by supporting tissue repair. Further trials will help confirm these findings in humans. ^{1 2 5 6 7}

Who Is on the Research Team?

Kelly Garrett, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Adults over 18 with chronic anal fissures not healed by standard treatments, who have stable vital signs and are willing to use contraception. Excluded are those with severe organ issues, active infections or allergies to DMSO, recent major surgery/trauma, substance abuse affecting study compliance, pregnant/breastfeeding women, and certain other health conditions.

Inclusion Criteria

I have had an anal fissure for more than 6 weeks.

Vital signs upon screening: Blood pressure: systolic ≥ 90 and < 140; and diastolic ≥ 60 and < 90. Breathing: ≥ 12 and ≤ 20 breaths per minute. Pulse: ≥ 60 and ≤ 100 beats per minute. Temperature: ≥ 97.8°F and ≤ 99.1°F (36.5°C to 37.3°C) O2 saturation: > 92%

My anal fissure did not improve after 1 month of medication and botulinum injections.

Exclusion Criteria

I might need an organ transplant soon due to my worsening condition.

I do not have an active infection but if I have HIV, it is under control.

Subjects who have known hypersensitivity or documented allergy to DMSO

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive percutaneous injections of E-CEL UVEC cell product along the sides of the fissure, spaced 3 to 4 weeks apart

6 months

Multiple visits (in-person) over 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with annual questionnaires provided electronically

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• E-CEL UVEC cells

Trial Overview The trial is testing the safety and healing effects of E-CEL UVEC cells injected directly into chronic anal fissures. It's for patients whose fissures haven't improved after at least one month of conventional treatment.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Local percutaneous injection of E-CEL UVEC cells around the anal fissure

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Angiocrine Bioscience

Industry Sponsor

Trials

6

Recruited

250+

Published Research Related to This Trial

Cultured autologous oral mucosal epithelial cell sheets (CAOMECS) were found to be safe and effective for treating total bilateral corneal limbal epithelial stem cell deficiency (LSCD) in a study involving 26 eyes from 25 patients, with 16 patients showing improvement after 360 days.

The treatment demonstrated a high success rate, with 22 out of 23 patients having no ulcers and 19 experiencing reduced severity of eye surface issues, indicating CAOMECS could be a promising alternative to traditional transplant methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultured autologous oral mucosal epithelial cell sheet (CAOMECS) transplantation for the treatment of corneal limbal epithelial stem cell deficiency. Burillon, C., Huot, L., Justin, V., et al.[2013]

In a study involving 24 rabbits, the introduction of 5-Fluorouracil into the anterior chamber during eye surgery did not show any statistically significant differences in corneal endothelial cell health compared to the control group using BSS-Plus.

The study measured endothelial cell surface area and form factor, indicating that 5-Fluorouracil may be safe for use in this context without adversely affecting corneal endothelium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Morphometry (Sketch PC) of the corneal endothelium after injection of 5-fluorouracil into the anterior chamber]. Ruiz Moreno, JM., Medrano Lopez, M., Alio y Sanz, JL.[2013]

Cultured epidermal allografts, created from keratinocytes of the patient's mother, were successfully used to treat chronic facial erosions in a patient with junctional epidermolysis bullosa.

The treatment resulted in significant re-epithelialization over four grafting procedures, suggesting that this method is a promising option for managing chronic erosions associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic erosions of junctional epidermolysis bullosa with human epidermal allografts. Hill, JC., Grimwood, RE., Parsons, DS.[2019]

Combining corneal epithelial cells with genetically modified embryonic stem cells (ESCs-TK) significantly enhanced epithelial proliferation, resulting in a thicker corneal epithelium compared to using corneal epithelial cells alone, as shown in a study involving perfusion culture and various cellular assays.

In a rabbit model, the ESCs-TK group demonstrated superior epithelial barrier functions and wound healing abilities, indicating that this coculture system could be a promising approach for corneal tissue engineering, with the added safety of being able to eliminate the ESCs-TK using ganciclovir.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstruction of Highly Proliferative Auto-Tissue-Engineered Lamellar Cornea Enhanced by Embryonic Stem Cell. Zhou, Q., Liu, Z., Wu, Z., et al.[2015]

Human amniotic epithelial cells (HAECs) can successfully differentiate into corneal epithelial-like cells when co-cultured with human corneal epithelial cells (CECs) for two weeks, indicating their potential for corneal tissue engineering.

The induced HAECs showed increased expression of key proteins and mRNAs associated with corneal epithelial cells, suggesting that HAECs could serve as effective seed cells for reconstructing corneal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Differentiation of human amniotic epithelial cells (HAECs) into corneal epithelial cells induced by co-culture of HAECs and corneal epithelial cells in vitro]. Liu, X., Chen, J., Zhou, Q., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06456073

NCT06456073 | E-CEL UVEC Treatment for Anal Fissures The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure. Detailed ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/condition/328/anal-fissures

Anal Fissures Clinical Research Trials This research study is being done because, in animal studies, E-CEL UVEC cells have been shown to aid in restoring or accelerating the normal healing in various ...

3. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/an-open-label-single-center-investigator-initiated-phase-1b-trial-of-e-cel-uvec-cell-therapy-for-the-treatment-of-chronic-anal-fissure

An Open-Label, Single-Center, Investigator Initiated Phase ... This research study is being done because, in animal studies, E-CEL UVEC cells have been shown to aid in restoring or accelerating the normal healing in various ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-e-cel-uvec-treatment-anal-fissures-trial-nct06456073

E-CEL UVEC Treatment for Anal Fissures Potential benefits include healing of your chronic anal fissure if the experimental treatment is effective. You will also receive careful monitoring and follow- ...

5. withpower.com withpower.com/trial/phase-1-fissure-in-ano-5-2024-08385

E-CEL UVEC Cells for Anal Fissures The study is being conducted to determine if E-CEL UVEC cell injections will be safe and would have any effects on healing of the anal fissure. Show more. Will ...

6. trialx.com trialx.com/clinical-trials/listings/241552/e-cel-uvec-as-an-adjunct-cell-therapy-for-treatment-of-anal-fistulas/

E-CEL UVEC as an Adjunct Cell Therapy for Treatment ... The purpose of this study is to test the safety of E-CEL UVEC® cells and see what effects (good and bad) it has on your anal fistula. It is ...

7. veri.larvol.com veri.larvol.com/news/ab-205/drug

News - AB-205 AB-205 appears to be safe and potentially effective in subjects undergoing HDT-AHCT for lymphoma. Compared to published rates of 24-41% for G ≥3 OM (Singer ...