A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial

• Sponsor: Anterogen Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03183934
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.

Condition or Disease	Intervention/Treatment	Phase
Dystrophic Epidermolysis Bullosa	Biological: ALLO-ASC-DFU

Detailed Description

This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Dystrophic Epidermolysis Bullosa.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
• Anticipated Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jun 1, 2020

Outcome Measures

Primary Outcome Measures

1. Safety assessed by clinically measured abnormality of laboratory tests and adverse events [Every time of visit for follow up to 24 months]

   Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Secondary Outcome Measures

1. Area of re-epithelization [Every time of visit for follow up to 24 months]

   Time taken to re-epithelization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.

2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam Severence Hospital	Seoul		Korea, Republic of	135-720

Sponsors and Collaborators

• Anterogen Co., Ltd.

Investigators

• Principal Investigator: Su Chan Kim, PhD, Gangnam Severence Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anterogen Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03183934
• Other Study ID Numbers: ALLO-ASC-EB-102
• First Posted: Jun 12, 2017
• Last Update Posted: Jun 12, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Anterogen Co., Ltd.: Epidermolysis Bullosa; Stem cell
• Additional relevant MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica

Study Results

No Results Posted as of Jun 12, 2017