Perianal Fistula Due to Crohn's DiseasePhase 1NCT05039411
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease
A Phase 1 study testing PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells in people with Perianal Fistula Due to Crohn's Disease and Fistula in Ano, run by CryoCord Sdn Bhd at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula Due to Crohn's Disease, Fistula in Ano
- What is being tested?
- PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Centre
Kuala Lumpur, 59100
April Camilla Roslani, Prof. Dr., +603-7949 2050, april@ummc.edu.my
April Camilla Roslani, Prof. Dr.
About this study
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
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).
Read the 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.
- Being tested
- PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
- Keywords
- Perianal fistula, Crohn's Disease, Umbilical cord mesenchymal stem cells (UC-MSCs), Allogeneic stem cells
- Medical subject headings
- Rectal Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem CellsBiological
All patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit.
| Study group | Role | What they receive |
|---|---|---|
| PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells | Experimental | 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. Receives: Biological: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, an average of 1.5 year
Secondary outcomes (1)
Clinical healing
Mainly on re-epithelialization of external opening
Measured: Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal Fistula Due to Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CryoCord Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- April Camilla Roslani, Prof. Dr., Principal investigator, Department of Surgery, Faculty of Medicine, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039411
- Sponsor's protocol ID
- CCSB-CT-PF-01-2021 (Ver4.0)
- Status last verified
- May 2025
- First submitted
- 1 Sep 2021
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05039411
- Acronym / sponsor ID
- CCSB-CT-PF-01-2021 (Ver4.0)
- Keywords
- Perianal fistula, Crohn's Disease, Umbilical cord mesenchymal stem cells (UC-MSCs), Allogeneic stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- CryoCord Sdn BhdIndustry (pharma, biotech, devices)
- Collaborators
- University of Malaya
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells | Experimental | Biological: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem CellsA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem CellsAll patients will receive a total of 60 million PF2020-CELL (UC-MSCs) cells per treatment visit. | Biological | PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells |
Primary outcome
No incidence of treatment-emergent adverse events (TEAEs)
Time frame: 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.
1 secondary outcome
Clinical healing
Time frame: Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
Related trials for Perianal Fistula Due to Crohn's Disease
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Perianal Fistula Due to Crohn's Disease
RecruitingPhase 4
TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
April Camilla Roslani, Prof. Dr. principal investigator
Department of Surgery, Faculty of Medicine, University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells in people with Perianal Fistula Due to Crohn's Disease and Fistula in Ano, run by CryoCord Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact April Camilla Roslani, Prof. Dr. (+603-7949 2050, april@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No incidence of treatment-emergent adverse events (TEAEs) (time frame: Throughout study completion, an average of 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.