Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

Kangstem Biotech

Status: Unknown

Conditions: Crohn's Disease

Treatments: Biological: stem cells

Study type: Observational

Funder types: Industry

Identifiers

NCT02926300

KSTHD_FURESTEM-CD-EXT

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.

Full description

This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who has history of FURESTEM-CD Inj. injection at least once.
• patients who understand and voluntarily sign an informed consent form.

Exclusion criteria

• any other condition which the Principle Investigator judges would make subject unsuitable for study participation.