Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
This study has been completed.
Sponsor:
Anterogen Co., Ltd.
Information provided by:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00992485
First received: September 29, 2009
Last updated: May 7, 2010
Last verified: May 2010
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Purpose
Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Fistula |
Drug: ADIPOPLUS |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy |
Resource links provided by NLM:
Further study details as provided by Anterogen Co., Ltd.:
Primary Outcome Measures:
- Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Closure of fistula [ Time Frame: week 4 ]
- Investigator satisfaction [ Time Frame: week 4 and week 8 ]
- Patient satisfaction [ Time Frame: week 4 and week 8 ]
- Digital photography [ Time Frame: day 1, week 4 and week 8 ]
| Enrollment: | 9 |
| Study Start Date: | November 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: autologous adipose derived stem cell |
Drug: ADIPOPLUS
autologous adipose-derived stem cell
Other Name: ADIPOPLUS
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Older than 18 years
- Prior diagnosis of Crohn's disease
- patients who have Crohn's fistula
- negative for urine beta-HCG for woman of childbearing age
- agreement to participate, with signed informed-consent
Exclusion Criteria:
- patients who have allergy to bovine-derived materials or an anesthetic
- patients with a diagnosis of auto immune disease except for Crohn's disease
- Diagnosis of HBV, HCV, HIV and other infectious disease
- Patients who have a symptom of septicemia
- Patients with a diagnosis of active Tuberculosis
- Patients who are pregnant or breast-feeding
- Patients who are unwilling to use an "effective" method of contraception during the study
- Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
- Patients who is sensitive to Fibrin glue
- Patients who have a clinically relevant history of abuse of alcohol or drugs
- Insufficient adipose tissue for manufacturing of ADIPOPLUS
- Patients who are considered not suitable for the study by investigator
- Patients who have history of surgery for malignant cancer in the past 5 years
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mihyung Kim, Director |
| ClinicalTrials.gov Identifier: | NCT00992485 History of Changes |
| Other Study ID Numbers: | ANTG-ASC-201 |
| Study First Received: | September 29, 2009 |
| Last Updated: | May 7, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Crohn Disease Fistula Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013