Fistula in Ano, Perianal Fistula Due to Crohn's Disease
Conditions
Keywords
Perianal fistula, Crohn's Disease, Umbilical cord mesenchymal stem cells (UC-MSCs), Allogeneic stem cells
Brief summary
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).
Detailed description
Design and Investigation: Number of Patients: 5 (including a consideration of 20% \[1 patient\] dropout from the trial) Dosage and mode of administration Dosage: A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed. Mode of administration: The procedure involves localizing the fistulous tract, performing curettage and closing the internal opening, and the injection of PF2020-CELL (UC-MSCs). The indicated dose of PF2020-CELL (UC-MSCs) will be injected starting from the tissues around the internal orifice or orifices and then progressing towards the external opening.
Interventions
BIOLOGICALPF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
All patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit.
Sponsors
University of Malaya
CryoCord Sdn Bhd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will receive a total of 60 million cells per visit for 5 consecutive visits, with a 6-12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No incidence of treatment-emergent adverse events (TEAEs) | Throughout study completion, an average of 1.5 year | example of TEAEs are pyrexia (non-persistent fever, \<38.5°C), infection, perianal abscess, enlargement of fistula & allergic reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical healing | Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits) | Mainly on re-epithelialization of external opening |
Countries
Malaysia
Contacts
Primary ContactApril Camilla Roslani, Prof. Dr.
Outcome results
None listed