A Phase I clinical study to evaluate the safety and efficacy of allogenic adipose-derived stem cells in the patients with Crohn's fiatula.

A Phase I dose escalation clinical study to evaluate the safety and efficacy of ALLO-ASC(Allogenic adipose-derived stem cells) in the patients with Crohn's fistula.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000188

Enrollment

Registered

2011-09-23

Start date

2011-09-26

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Others : Allo-ASC 1xE7 cells/ml 3 patients is to be enrolled. If there is no safety issue at week 4, 3 more patients are enrolled to be injected with Allo-ASC 3xE7 cells/ml.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18~60 years old 2. Diagnosed with Crohn's disease 3. Crohn's fistula which has been lasted at least for 3 months 4. If a patient is taking aminosalicylate, corticosteroid, methotrexate, azathioprine, antibiotics or mercaptopurine, those dosages should be stabilized at least 8 weeks before screening. If a patient had been taking those medications but not now, he should have stopped at least 4 weeks before visit. 5. Negative for beta-HCG pregnancy test 6. Who can submit a written consent form and is obliged to Clinical Trial Protocol.

Exclusion criteria

Exclusion criteria: 1. Who has been participated in other clinical trials within 30 days or does not passed at least 5 times period of half-life of other investigational drugs. 2. Medical history with Variant Creutzfeld Jacobs Disease 3. Allergic to anesthetics or bovine protein 4. Autoimmune disease other than Crohn's disease 5. Infectious disease such as HBV, HCV or HIV 6. Sepsis 7. active tuberculosis 8. pregnant or breast feeding woman 9. who is not willing to use effective contraceptive methods. 10. Inflammatory Bowel disease other than Crohn's disease 11. Allergic to fibrin glue 12. Who has a history of alcohol or drug abuse or habitual smoking 13. active crohn's disease with CDAI score > 200 14. surgical history of malignant tumor within 5 years (except carcinoma in situ) 15. diagnosed with malignant tumor 16. fistula's diameter > 2 cm 17. who has experienced with cyclosporine or infliximab in 3 months before screening

Design outcomes

Primary

Measure	Time frame
Safety(laboratory hematology, adverse effects, immunological response, tolerance);Proportion of patients with completely healing	—

Secondary

Measure	Time frame
Proportion of patients with more than 50% healed fistula;Sustained safety and efficacy(recurrence or adverse effects)	—

Countries

Korea, Republic of

Contacts

Public ContactMH Kim

Anterogen

Outcome results