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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Stromal-vascular fraction

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring SVF, stromal-vascular fraction, Stem cell therapy

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Non-inclusion Criteria:

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
Clinically significant abnormalities in results of laboratory tests
Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction
Medical history of heterotopic ossifications
Patients prescribed for glycoprotein inhibitors treatment

Exclusion Criteria:

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

Sites / Locations

Swiss Medica XXI Century S.A.
IM Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SVF injection

Arm Description

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

Outcomes

Primary Outcome Measures

Serious adverse events (SAEs)

Types, probability and severity of treatment emergent SAEs

Serious adverse reactions (SARs)

Types, probability and severity of treatment emergent SARs

Secondary Outcome Measures

Quality of life monitoring-1

Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36). SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health

Quality of life monitoring-2

Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a patient reported joint-specific score, which assesses: patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

Knee pain intensity monitoring

Knee pain intensity assessed by Visual Analog Pain Scale (no pain=0; maximum pain=100 mm)

Changes in knee joint structure-1

Changes in knee joint structure assessed by ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis)

Changes in knee joint structure-2

Changes in knee joint structure assessed by X-ray (joint space width, bone contour, presence of osteophytes and sclerosis)

Changes in knee joint structure-3

Changes in knee joint structure assessed by MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments)

Changes in knee function

Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS). KSS consists of 4 separate sub-scales: "Objective" Knee Score (seven items: 100 points), Patient Satisfaction Score (five items: 40 points), Patient Expectation Score (three items: 15 points), Functional Activity Score (19 items: 100 points). Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

Full Information

NCT ID

NCT04050111

First Posted

June 7, 2019

Last Updated

August 6, 2019

Sponsor

Swiss Medica XXI Century S.A.

1. Study Identification

Unique Protocol Identification Number

NCT04050111

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 21, 2019 (Anticipated)

Primary Completion Date

February 22, 2021 (Anticipated)

Study Completion Date

August 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Medica XXI Century S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Patients with 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

SVF, stromal-vascular fraction, Stem cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SVF injection

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Stromal-vascular fraction

Intervention Description

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

Primary Outcome Measure Information:

Title

Serious adverse events (SAEs)

Description

Types, probability and severity of treatment emergent SAEs

Time Frame

4 weeks after treatment

Title

Serious adverse reactions (SARs)

Description

Types, probability and severity of treatment emergent SARs

Time Frame

4 weeks after treatment

Secondary Outcome Measure Information:

Title

Quality of life monitoring-1

Description

Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36). SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health

Time Frame