Clinical Trials Logo
  1. Home
  2. Burn
  3. NCT03183648
  4. Details
NCT03183648 Clinical Trial

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

Burn Clinical Trial

Official title:
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03183648
Other study ID # ALLO-ASC-BI-202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 29, 2016
Est. completion date June 2023

Study information
Verified date August 2023
Source Anterogen Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Description:

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 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 burn.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date June 2023
Est. primary completion date April 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ALLO-ASC-DFU
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 burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Locations
Country Name City State
Korea, Republic of Hallym university Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Evaluation of AE up to 24 months
Secondary Vancouver Burn Scar Scale Evaluation of Vancouver Burn Scar Scale Every time of visit for follow up to 24 weeks
See also
  Status Clinical Trial Phase
Withdrawn NCT01302457 - Oral Care Study on Burn Patients N/A
Completed NCT02729259 - H2O VR for Burns 2015 N/A
Completed NCT01965340 - Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission N/A
Withdrawn NCT01225107 - Effect of Cranberry Extract on Infections in Burn Patients N/A
Completed NCT01983280 - The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients N/A
Completed NCT00591448 - Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients N/A
Active, not recruiting NCT02083900 - Use of Banana Leaf Dressing on Donor Site Wounds Phase 2
Completed NCT00242970 - Hypertrophic Scarring After Facial Burn Phase 2
Completed NCT00585325 - Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes N/A
Terminated NCT00591162 - Bone Disease in Severely Burned Children Phase 2/Phase 3
Completed NCT03183622 - A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial N/A
Terminated NCT02452255 - Fenofibrate and Propranolol in Burn Patients Phase 2/Phase 3
Completed NCT02427659 - VR High Tech Pain Control Burn Wound Care N/A
Not yet recruiting NCT00253279 - Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans Phase 1
Completed NCT04516148 - A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting Phase 4
Withdrawn NCT02029261 - Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
Completed NCT00993889 - Virtual Reality Analgesia During Pediatric Physical Therapy N/A
Terminated NCT01062191 - Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl N/A
Completed NCT02394873 - A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound Phase 1
Completed NCT00239668 - Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors