Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCryoCord Sdn Bhd
About this trial
Objectives:
Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease
Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
Biological/VaccineAll patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem CellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
No incidence of treatment-emergent adverse events (TEAEs)
example of TEAEs are pyrexia (non-persistent fever, \<38.5°C), infection, perianal abscess, enlargement of fistula \& allergic reaction.
Time frame
Throughout study completion, an average of 1.5 yearSecondary outcomes
1
Clinical healing
Mainly on re-epithelialization of external opening
Time frame
Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
CryoCord Sdn Bhd
Lead sponsor
University of Malaya
Collaborator
Source ClinicalTrials.gov