The Treatment of Crohn's Perianal Fistulas by Human Placenta Derived Mesenchymal Stem Cells (MSCs) Hydrogel: a Phase 2 Study

The Treatment of Crohn's Perianal Fistulas by Human Placenta Derived Mesenchymal Stem Cells Hydrogel: a Phase 2, Prospective, Single-Center, Double-Bland, Randomized Controlled Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100046546

Enrollment

Unknown

Registered

2021-05-21

Start date

2021-06-01

Completion date

Unknown

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn’s Perianal Fistulas

Interventions

MSCs treatment group:Inject MSCs hydrogel into Crohn's perianal fistulas

control group:Inject hydrogel without MSCsinto Crohn's perianal fistulas

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 60 years; 2. Refractory Crohns Perianal Fistulas with 1-2 internal orifices and 1-3 fistulas; 3. Crohns disease duration over 3 months; 4. Crohn's Disease Activity Index (CDAI) Score 4 weeks; immunomodulators and biologics > 8weeks).

Exclusion criteria

Exclusion criteria: 1. Patients with intestinal obstruction or stenosis or perianal abscess; 2. Pregnant or lactating patients; 3. Patients who need antibiotics treatment; 4. Patients with rectovaginal fistulas; 5. Patients with more than 2 internal openings of fistulas; 6. Patients with stenosis or perforate Crohns disease; 7. Patients with perianal infection; 8. Patients with rectal or anal stenosis so that unable to be injected locally; 9. Patients with acute colitis; 10. Patients with liver or kidney failure; 11. Patients enrolled in another clinical trial within 1 month; 12. Patients who reject MRI examination; 13. Patient who under medicine adjustment; 14. Co-infection with HIV; 15. Co infection with HBV or tuberculosis; 16. Patients with opportunistic infection within 6 months, or with severe infection within 3 months; 17. Patients with malignant neoplasm within 5 years; 18. Patients with lymphoproliferative disorders.

Design outcomes

Primary

Measure	Time frame
fistula clinical respone (classified as: healing, improvement, noneresponse);	—

Secondary

Measure	Time frame
fistula clinical respone (classified as: healing, improvement, noneresponse);perianal disease activity index;Vaizey Fecal incontinence score;Crohn's disease activity index;life quality;level of C-reactive protein;safety;	—

Countries

China

Contacts

Public ContactLan Ping

The Sixth Affiliated Hospital, Sun Yat-Sen University

lanping@mail.sysu.edu.cn+86 13710316769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026