Knee OsteoarthritisPhase 2NCT04050111
The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis
A Phase 2 study testing Stromal-vascular fraction in people with Knee Osteoarthritis, run by Swiss Medica XXI Century S.A. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Stromal-vascular fraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Aug 2019to 22 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 24Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Russia1 site
Swiss Medica XXI Century S.A.
Moscow, 127521
Sergey L Mikheev, MD, PhD, +7-495-6180116, mikheev@swissmedica21.com
Ilya I Eremin, MD, PhD, +7-495-6180116, ieremin@swissmedica21.com
Serbia1 site
IM Clinic
Belgrade
Igor Bolbukh, MD, +38162256891, doctor_bol@mail.ru
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Stromal-vascular fraction
- Keywords
- SVF, stromal-vascular fraction, Stem cell therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal-vascular fractionBiological
Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Stromal-vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events (SAEs)
Types, probability and severity of treatment emergent SAEs
Measured: 4 weeks after treatment
Serious adverse reactions (SARs)
Types, probability and severity of treatment emergent SARs
Measured: 4 weeks after treatment
Secondary outcomes (7)
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
Measured: Follow up to completion (up to 24 weeks after treatment)
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.
Measured: Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity monitoring
Knee pain intensity assessed by Visual Analog Pain Scale (no pain=0; maximum pain=100 mm)
Measured: Follow up to completion (up to 24 weeks after treatment)
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)
Measured: Follow up to completion (up to 24 weeks after treatment)
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)
Measured: Follow up to completion (up to 24 weeks after treatment)
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)
Measured: Follow up to completion (up to 24 weeks after treatment)
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.
Measured: Follow up to completion (up to 24 weeks after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start21 Aug 2019 (estimated)
- Primary completion22 Feb 2021 (estimated)
- Study completion22 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Medica XXI Century S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey L Mikheev, MD, PhD, Principal investigator, Head of Swiss Medica XXI Century S.A.Ilya I Eremin, MD, PhD, Principal investigator, Chief scientific officer of Swiss Medica XXI Century S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050111
- Sponsor's protocol ID
- SM-001
- Status last verified
- Aug 2019
- First submitted
- 7 Jun 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04050111
- Acronym / sponsor ID
- SM-001
- Conditions
- Knee Osteoarthritis
- Keywords
- SVF, stromal-vascular fraction, Stem cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Swiss Medica XXI Century S.A.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2019 (estimated)
- Primary completion
- 22 Feb 2021 (estimated)
- Study completion
- 22 Aug 2021 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVF injection | Experimental | Biological: Stromal-vascular fractionSubjects 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal-vascular fractionConcentrate of stromal-vascular fraction of cells derived from autologous adipose tissue | Biological | SVF injection |
Primary outcome
Serious adverse events (SAEs)
Time frame: 4 weeks after treatment
Types, probability and severity of treatment emergent SAEs
Serious adverse reactions (SARs)
Time frame: 4 weeks after treatment
Types, probability and severity of treatment emergent SARs
7 secondary outcomes
Quality of life monitoring-1
Time frame: Follow up to completion (up to 24 weeks after treatment)
Quality of life monitoring-2
Time frame: Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity monitoring
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-1
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-2
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-3
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee function
Time frame: Follow up to completion (up to 24 weeks after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey L Mikheev, MD, PhD principal investigator
Head of Swiss Medica XXI Century S.A.
Ilya I Eremin, MD, PhD principal investigator
Chief scientific officer of Swiss Medica XXI Century S.A.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stromal-vascular fraction in people with Knee Osteoarthritis, run by Swiss Medica XXI Century S.A. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergey L Mikheev, MD, PhD (+7-495-6180116, mikheev@swissmedica21.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (SAEs) (time frame: 4 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.