Evaluate the Distribution and Dynamic Behavior of TH-SC01 Cells in Vivo in Patients With Perianal Fistula

Inclusion Criteria:

1. Signed informed consent

2. Subjects with Crohn's disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis andTreatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with activeperianal fistula and non active luminal CD defined by a CDAI ≤ 200.

3. For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤the number of external openings ≤3, the fistula of the patient needs to be drainedsmoothly

4. All subjects and their partners were not planning to have a child from screening tothe end of the trial and agreed to use effective non-drug contraception during thetrial.

5. ECOG score 01, ASA grade III

6. Subjects failed to respond to adequate treatment with any of the conventionalantibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosisfactor-α (TNF-α) monoclonal antibodies and other biological agents.

Exclusion Criteria:

1. Subjects with active infection evaluated by the investigator.

2. Subjects with Crohn's disease requiring immediate therapy.

3. Subjects with abscess or collections >2 cm.

4. Subjects with rectal and/or anal stenosis and/or active proctitis.

5. Subjects who treated with systemic steroids in the 4 weeks prior to stem cellsadministration.

6. Subjects with abnormal laboratory results: liver function: total bilirubin >=1.5 × ULN, and aspartate aminotransferase (AST) and alanineaminotransferase (ALT) >=2 × ULN; renal function: creatinineclearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serumcreatinine >=1.5 × upper limit of normal (ULN).

7. Subjects with malignant tumors or a history of malignant tumors.

8. Subjects with severe, progressive, uncontrolled hepatic, hematological,gastrointestinal (except Crohn's disease), endocrine, pulmonary,cardiac, neurological, psychiatric, or cerebral diseases.

9. Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody)positive.

10. Subjects allergic to Human serum albumin, human platelet lysate, gentamicin sulfate,anesthetic drug

11. Subjects who has received stem cells therapy.

12. Subjects who has major surgery or severe trauma within 6 months prior to thescreening period.

13. Subjects who has received any investigational drug within 3 months prior to thescreening.

14. Subjects deemed inappropriate by the investigator to participate in this clinicaltrial.

15. The female participant who is pregnant, or is lactating.

16. Not suitable for PET/CT examination.

17. Participants considered inappropriate to participate in this clinical trial