Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-12 @ 8:25 AM
Study NCT ID:
NCT02827851
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2016-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy
Sponsor:
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Organization:
Study Overview
Official Title:
Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.This is a single arm study with no control.
Detailed Description:
Patients undergone arthroscopic debridement for knee osteoarthritis will be subjected to abdominal liposuction under local anaesthesia. Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution. Isolated SVF will be administered in a single dose into anterior part of knee joint cavity 28 days after arthroscopy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: