E-CEL UVEC Cells for Anal Fissures

Overseen By Rohit Rasane

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

Trial Summary

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.

How is the treatment E-CEL UVEC cells for anal fissures different from other treatments?

E-CEL UVEC cells are a unique treatment option for anal fissures as they involve the use of specialized cells that may promote healing and tissue regeneration, unlike traditional treatments that typically focus on symptom relief or surgical intervention. ^{1 2 3 4 5}

What is the purpose of this trial?

This clinical trial is being conducted by investigators who are colorectal surgeons. Eligible study participants will receive the experimental treatment E-CEL UVEC cells by direct injection into the anal fissure. 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.

Research Team

Kelly Garrett, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

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

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%

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reconstruction of Highly Proliferative Auto-Tissue-Engineered Lamellar Cornea Enhanced by Embryonic Stem Cell. [2015]

2. China 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]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Cultured autologous oral mucosal epithelial cell sheet (CAOMECS) transplantation for the treatment of corneal limbal epithelial stem cell deficiency. [2013]

4. France pubmed.ncbi.nlm.nih.gov

[Morphometry (Sketch PC) of the corneal endothelium after injection of 5-fluorouracil into the anterior chamber]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic erosions of junctional epidermolysis bullosa with human epidermal allografts. [2019]