A Phase I study on the Safety Allogeneic Human Umbilical Cord Mesenchymal Stem Cells(PF2020-CELL) for Perianal Fistulas in patients with Crohn`s disease

Stem Cell Therapy for Perianal Fistulas in Crohn's Disease

General Information

Research Type

Interventional

Description

Allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) infusion in patients with complex perianal fistula is expected to result in:
(1) Primary Measures: Safe and feasible usage without serious adverse events (SAE)
(2) Secondarary Measures: (a) Improvement /closure of openings and Re-epithelialization (b) Improvement in inflammatory markers

In this study, we will be utilizing the conventional 3 + 3 design, as described by Storer in 1989, which is best used in dose-escalation clinical studies. The 3 + 3 dose-escalation method remains the most popular method employed by researchers in phase 1 trials. Based on this design, a total of 7 patients will be recruited which includes a consideration of 20% (one patient) possible patients withdrawal from the trial.

Study Information

RMK Priority Area

Non-Communicable Disease

Research Level

Clinical Practice

Research Keyword

Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs); perianal fistula; Crohn's disease

Inclusion & Exclusion Criteria

Inclusion Criteria

Adult men and women age 18 years and above|Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy|Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.|Fit for surgery

Exclusion Criteria

Informed consent refusal|Pregnancy or breastfeeding women|Current diagnosis of active cancer or remission for less than 5 years|Evidence of active sepsis or significant localised infection|Patients with HIV, HBV, HCV or treponema infection, whether active or latent|Patients with documented allergies.|Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration|Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug|Patients with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids)

Study Timeline

Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data

Aug, 01 2022

Expected / Actual Date Study Completed

Jun, 01 2024

Expected / Actual Duration of Study Enrollment / Data Collection

95 weeks