The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis

NCT04050111 | Unknown Phase 2 DMC

• 1 other identifier: SM-001
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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. All patients will receive cell therapy.This is a single arm study with no control.

Conditions

Knee Osteoarthritis

Keywords

SVF; stromal-vascular fraction; Stem cell therapy

Outcome Measures

Primary Outcomes (2)

• Serious adverse events (SAEs)

  Types, probability and severity of treatment emergent SAEs

  4 weeks after treatment

• Serious adverse reactions (SARs)

  Types, probability and severity of treatment emergent 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)

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. Interventions: Procedure: Liposuction Other: SVF isolation Other: Intraarticular administration of autologous SVF

Biological: Stromal-vascular fraction

Interventions

Stromal-vascular fraction BIOLOGICAL

Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue

SVF injection

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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: 20-85 years of age, 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

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

Sponsors & Collaborators

• Swiss Medica XXI Century S.A.: lead

Study Sites (2)

Swiss Medica XXI Century S.A.

Moscow, 127521, Russia

Location

IM Clinic

Belgrade, Serbia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sergey L Mikheev, MD, PhD

  Head of Swiss Medica XXI Century S.A.

  PRINCIPAL INVESTIGATOR

• Ilya I Eremin, MD, PhD

  Chief scientific officer of Swiss Medica XXI Century S.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey L Mikheev, MD, PhD

CONTACT

+7-495-6180116; mikheev@swissmedica21.com

Ilya I Eremin

CONTACT

+7-495-6180116; ieremin@swissmedica21.com

Study Design

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

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: August 8, 2019
• Study Start: August 21, 2019
• Primary Completion: February 22, 2021
• Study Completion: August 22, 2021
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); RU (1)