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Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039411
Recruitment Status : Not yet recruiting
First Posted : September 9, 2021
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
CryoCord Sdn Bhd

Tracking Information
First Submitted Date  ICMJE September 1, 2021
First Posted Date  ICMJE September 9, 2021
Last Update Posted Date September 9, 2021
Estimated Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
Incidence of any treatment-emergent adverse events (TE-AEs) [ Time Frame: 24 weeks ]
Any composite of perianal sepsis, persistence of the fistula and allergic reaction.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
Clinical healing [ Time Frame: 24 and/or 48 weeks ]
Mainly on re-epithelialization of external opening
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease
Official Title  ICMJE A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease
Brief Summary The primary objective of this study is to demonstrate the safety of allogeneic human umbilical cord mesenchymal stem cells (UC-MSCs) (product code: PF2020-CELL) administered by intralesional injection in patients with Crohn's fistula. The secondary objective is to compare the safety of a single/multiple UC-MSCs injection in a dose escalating manner as well as on the efficacy of stem cells treatment (reepithelialization of the external openings of fistula)
Detailed Description

Design and Investigation:

Dosage and mode of administration

  1. First Dosage

    • 125 million cells UC-MSCs to be injected
    • Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs
  2. Second dosage

    • 150 million cells UC-MSCs to be injected
    • Procedure: Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with intralesional injection of an indicated dose of UC-MSCs
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
First dose is125 million cells and only proceed to second dose of 150 million cells for patients clinically not recovered after 24 weeks from first dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Perianal Fistula Due to Crohn's Disease
  • Fistula in Ano
Intervention  ICMJE Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs)
All patients to receive 1st dose of 125 million UC-MSCs and the 2nd dose of 150 million UC-MSCs only if patients have no clinical improvement post 24 weeks after 1st dose
Study Arms  ICMJE Experimental: Human umbilical cord mesenchymal stem cells (UC-MSCs)
All patients to receive allogeneic UC-MSCs via intralesional injection
Intervention: Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2021)
7
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 enrollment 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: April Camilla Roslani, Prof. Dr. +603-7949 2050 april@ummc.edu.my
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05039411
Other Study ID Numbers  ICMJE CCSB-CT-PF-01-2021 (Ver_01)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CryoCord Sdn Bhd
Study Sponsor  ICMJE CryoCord Sdn Bhd
Collaborators  ICMJE University of Malaya
Investigators  ICMJE
Principal Investigator: April Camilla Roslani, Prof. Dr. Faculty of Medicine, University of Malaya
PRS Account CryoCord Sdn Bhd
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP