Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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)

Condition or disease Intervention/treatment Phase
Perianal Fistula Due to Crohn's Disease Fistula in Ano Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs) Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
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
Official Title: 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
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Human umbilical cord mesenchymal stem cells (UC-MSCs)
All patients to receive allogeneic UC-MSCs via intralesional injection
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical healing [ Time Frame: 24 and/or 48 weeks ]
    Mainly on re-epithelialization of external opening



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039411


Contacts
Layout table for location contacts
Contact: April Camilla Roslani, Prof. Dr. +603-7949 2050 april@ummc.edu.my

Locations
Layout table for location information
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Contact: April Camilla Roslani, Prof. Dr.    +603-7949 2050    april@ummc.edu.my   
Principal Investigator: April Camilla Roslani, Prof. Dr.         
Sponsors and Collaborators
CryoCord Sdn Bhd
University of Malaya
Investigators
Layout table for investigator information
Principal Investigator: April Camilla Roslani, Prof. Dr. Faculty of Medicine, University of Malaya
Layout table for additonal information
Responsible Party: CryoCord Sdn Bhd
ClinicalTrials.gov Identifier: NCT05039411    
Other Study ID Numbers: CCSB-CT-PF-01-2021 (Ver_01)
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CryoCord Sdn Bhd:
Perianal fistula
Crohn's Disease
Umbilical cord mesenchymal stem cells (UC-MSCs)
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Rectal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases