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Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture

NCT02469792 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-21

No results posted yet for this study

Summary

Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.

Conditions

  • Anterior Cruciate Ligament Partial Rupture

Interventions

PROCEDURE

Liposuction

DEVICE

ADRC isolation

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

PROCEDURE

Arthroscopic surgery

OTHER

Intraarticular administration of autologous ADRC

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Sergey V Ivannikov, Professor · I.M. Sechenov First Moscow State Medical University

  • Ilya I Eremin, MD, PhD · Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469792 on ClinicalTrials.gov