Crohn's Disease
Conditions
Keywords
crohn's disease, stem cell therapy, inflammatory bowel disease, hUCB-MSC, UCB-MSC, Umbilical cord Blood, Rheumatoid Arthritis, RA, Stem cell, Cell therapy, Furestem, Mesenchymal stem cell, MSC
Brief summary
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.
Detailed 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).
Interventions
BIOLOGICALstem cells
IV infusion
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all kinds of adverse events which occur during the clinical sutdy | 114 weeks | Safety outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ratio of patients who is applicable to CDAI<150 | 114 weeks | Efficacy outcome |
| ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) | 114 weeks | Efficacy outcome |
Countries
South Korea
Contacts
Primary ContactEun-ji Kang
Outcome results
None listed