Clinical Study to Evaluate Efficacy & Safety of ASC & Fibringlue or

Clinical Trial Description

Experimental: ASC(Autologous Adipose-derived Stem Cells) and Fibringlue, Comparator: Fibringlue, Study type: Interventional, Study design: Randomized ;

Study Design

Related Conditions & MeSH terms

See also
Status	Clinical Trial	Phase
Completed	`NCT05742100` - Darvadstrocel for Crohn's Fistula in the Realworld
Completed	`NCT00992485` - Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula	Phase 1
Completed	`NCT01011244` - Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula	Phase 2

See also

Status

Clinical Trial

Phase

Completed

NCT05742100 - Darvadstrocel for Crohn's Fistula in the Realworld

Completed

NCT00992485 - Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Phase 1

Completed

NCT01011244 - Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04612465
Study type	Interventional
Source	Anterogen Co., Ltd.
Contact	KyuJoo Park, MD. Ph D
Phone	+82-02-2072-2901
Email	kjparkmd@plaza.snu.ac.kr
Status	Recruiting
Phase	Phase 3
Start date	January 9, 2020
Completion date	December 31, 2024

Clinical Study to Evaluate Efficacy and Safety of ASC and Fibringlue or Fibringlue in Patients With Crohn's Fistula

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms