NCT02827851

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2 knee-osteoarthritis

Timeline
Completed

Started May 2016

Typical duration for phase_2 knee-osteoarthritis

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

June 24, 2016

Last Update Submit

July 19, 2017

Conditions

Knee Osteoarthritis

Keywords

Damage of articular cartilageCartilage degenerationIntraarticular injectionSVFStromal vascular fractionAdipose-derived regenerative cells (ADRC)Adipose tissueStem cells

Outcome Measures

Primary Outcomes (2)

  • SAEs monitoring

    Types, probability and severity of treatment emergent serious adverse events (SAEs)

    4 weeks after treatment

  • SARs monitoring

    Types, probability and severity of treatment emergent serious adverse reactions (SARs)

    4 weeks after treatment

Secondary Outcomes (7)

  • Quality of life monitoring-1

    Follow up to completion (up to 24 weeks after treatment)

  • Quality of life monitoring-2

    Follow up to completion (up to 24 weeks after treatment)

  • Knee pain intensity monitoring

    Follow up to completion (up to 24 weeks after treatment)

  • Changes in knee joint structure-1

    Follow up to completion (up to 24 weeks after treatment)

  • Changes in knee joint structure-2

    Follow up to completion (up to 24 weeks after treatment)

  • +2 more secondary outcomes

Study Arms (1)

SVF injection

EXPERIMENTAL

Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate stromal vascular fraction of cells (SVF). After SVF isolation autologous cells suspension will be injected intraarticularly into knee joint.

Procedure: LiposuctionOther: SVF isolationOther: Intraarticular administration of autologous SVF

Interventions

LiposuctionPROCEDURE
SVF injection
SVF isolationOTHER

SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.

SVF injection
Intraarticular administration of autologous SVFOTHER
SVF injection

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain in the knee joint during more than a half day assessed by Visual Analog Pain Scale (score more than 40 mm)
  • At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
  • Patient is able to walk without assistance
  • Patient is familiar with Participant information sheet
  • Patient signed informed consent form
  • Medical history of endoprosthetic knee replacement
  • Medical history of lower extremity osteotomy
  • Medical history of knee surgery (including arthroscopy) during preceding 1 year prior to enrollment
  • Medical history of intraarticular injections during preceding 6 months prior to enrollment
  • Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed after clinically significant injury), intra-articular fractures, clinically significant varus or valgus deformities of lower limbs, septic arthritis, joint's inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis, osteonecrosis, hemophilia
  • Patients prescribed for immunosuppressive treatment
  • Medical history of systemic autoimmune and inflammatory diseases
  • Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
  • Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
  • Patients prescribed for systemic corticosteroids or other medications treatment with proven impact on bone or cartilage tissue metabolism
  • +7 more criteria

You may not qualify if:

  • Patient's refusal from the further participation in trial
  • Patient's refusal from compliance with the requirements of contraception during the participation in research
  • Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockcroft-Gault formula)
  • Confirmed syphilis, HIV, hepatitis B or C infections
  • Dropout Criteria:
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

Moscow, 121359, Russia

Location

Orenburg City Clinical Hospital #4

Orenburg, 460000, Russia

Location

Orenburg Regional Clinical Donor Blood Center

Orenburg, 460018, Russia

Location

Orenburg Regional Clinical Hospital

Orenburg, 460018, Russia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsBariatric SurgeryBariatricsObesity ManagementSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Rinat G Gilmutdinov, MD, PhD

    Orenburg Regional Clinical Donor Blood Center

    PRINCIPAL INVESTIGATOR

  • Sergey I Gilfanov, MD, PhD, Prof

    Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

    PRINCIPAL INVESTIGATOR

  • Andrey A Averyanov, MD, PhD

    Orenburg Regional Clinical Hospital

    PRINCIPAL INVESTIGATOR

  • Vadim A Kopylov, MD, PhD

    Orenburg City Clinical Hospital #4

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 11, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

November 1, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

RU(4)