OsteoarthritisPhase 1/2NCT02967874
Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
A Phase 1/2 study testing Intra-articular auto-SVFs injection and Hyaluronic Acid in people with Osteoarthritis and Joint Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Joint Disease, Osteoarthritis,Knee
- What is being tested?
- Intra-articular auto-SVFs injection and Hyaluronic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2016to Sep 2019
- Phase
- Phase 1/2
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 85 Years (Adult, Senior)
- Grade II or Grade III osteoarthritis of the knee joints using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray and physician review, and/or MRI
- Patients must have continued pain in the knee despite conservative therapies for at least 3 months
- Patients must be able to tolerate all study procedures
- Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
- Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol
Who cannot join
- Subjects with a BMI > 35
- Subjects who have had an injection in either knee in the prior 4 weeks, including corticosteroids, drugs of hyaluronic acid or platelet rich plasma (PRP).
- Subjects who have had surgery of either knee within 6 months prior to the screening visit
- Subjects those are allergic to drugs for local anesthesia
- Psychiatric disorders
- Hepatic or renal dysfunctions
Show all 12Show fewer
- Hemodynamic or respiratory instability
- HIV or uncontrolled bacterial, fungal, or viral infections
- Autoimmune diseases (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, etc)
- Pregnancy
- Malignancy
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Russia1 site
Institute of Fundamental and Clinical Immunology
Novosibirsk, 630099
About this study
Official title: Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues.
The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a treatment reduces pain, increases function and reduces stiffness in the knees of osteoarthritic subjects.
Read the detailed description
Subcutaneous human adipose tissue is an abundant and accessible cell source for applications in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be cultured in plastic ware to select and expand an adherent population known as adipose-derived stromal/stem cells.
Osteoarthritis is the most common joint disease that affects at least 20% of the world population. The disease usually begins at the age of 40 years. Radiographic signs of osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can cause severe pain and stiffness in the affected joints, thus reducing joint's functionality. Therefore a treatment that would reduce pain/stiffness and increase joint function would be of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in few clinical studies.
This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to determine safety and efficacy of a single injection of freshly isolated autologous SVFs into the knees of osteoarthritic patients (Grade II-III). In experimental group the participants (n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue will be processed to obtain the SVFs and patients will receive a single intra-articular injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel control group the participants (n=11) will receive a single intra-articular injection of hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs injection will be evaluated by assessment of the frequency and nature of adverse events occurring during or immediately after the procedure, and up to the one year following treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.
- Conditions
- Osteoarthritis, Joint Disease, Osteoarthritis,Knee, Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Being tested
- Intra-articular auto-SVFs injection, Hyaluronic Acid
- Keywords
- Adipose -Derived Stromal Vascular Fraction Cells, Knee Osteoarthritis, Intra-articular Administration, Liposuction
- Medical subject headings
- Osteoarthritis, Joint Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular auto-SVFs injectionProcedure or surgery
Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation
Hyaluronic AcidDrug
Also called Synocrom Forte
Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular auto-SVFs injection | Experimental | The participants will undergo a standard liposuction to harvest adipose tissue. The adipose tissue will then be processed to obtain the SVFs.
This group of subjects (n=16) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint). Receives: Procedure: Intra-articular auto-SVFs injection |
| Intra-articular Hyaluronic Acid | Active comparator | This group of subjects (n=11) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint). Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with adverse events
The safety of intra-articular injection of auto-SVFs will be evaluated by assessment of the frequency and nature of adverse events during or immediately after the procedure, and up to the 12-months following treatment
Measured: up to 12 months after treatment
Secondary outcomes (3)
Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits
The severity of joint pain, which is determined by the patient from 0 (no pain) to 10 points (unbearable pain), will be evaluated.
Measured: Baseline, 1, 3, 6 and 12 months after treatment
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Baseline, 1, 3, 6 and 12 months after treatment
Change in Ultrasonography of the knee joints
Measured: Baseline, 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander A Ostanin, Russian Academy of Medical Sciences
- Investigators
- Elena R Chernykh, MD, PhD, Study chair, Institute of Fundamental and Clinical ImmunologyAlexander A Ostanin, MD, PhD, Principal investigator, Institute of Fundamental and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967874
- Sponsor's protocol ID
- IFCI-10/11/2015
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2016
- Last updated
- 13 Sep 2019
- Results posted
- No
Publications
Michalek J, Moster R, Lukac L, Proefrock K, Petrasovic M, Rybar J, Capkova M, Chaloupka A, Darinskas A, Michalek J Sr, Kristek J, Travnik J, Jabandziev P, Cibulka M, Holek M, Jurik M, Skopalik J, Kristkova Z, Dudasova Z. WITHDRAWN: Autologous adipose tissue-derived stromal vascular fraction cells application in patients with osteoarthritis. Cell Transplant. 2015 Jan 20. doi: 10.3727/096368915X686760. Online ahead of print.
PubMed 25706817Garza GR, Palomera T, Dumanian GA, Dos-Anjos S. Use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of the knee: a feasibility and safety study. J Regen Med. 4(1), 2015 doi:10.4172/2325-9620.1000119
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02967874
- Acronym / sponsor ID
- IFCI-10/11/2015
- Conditions
- Osteoarthritis, Joint Disease, Osteoarthritis,Knee, Arthritis, Degenerative, Osteoarthrosis, Osteoarthrosis Deformans
- Keywords
- Adipose -Derived Stromal Vascular Fraction Cells, Knee Osteoarthritis, Intra-articular Administration, Liposuction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 18 Nov 2016 (estimated)
- 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.
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues.
The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a treatment reduces pain, increases function and reduces stiffness in the knees of osteoarthritic subjects.
Detailed description
Subcutaneous human adipose tissue is an abundant and accessible cell source for applications in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be cultured in plastic ware to select and expand an adherent population known as adipose-derived stromal/stem cells.
Osteoarthritis is the most common joint disease that affects at least 20% of the world population. The disease usually begins at the age of 40 years. Radiographic signs of osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can cause severe pain and stiffness in the affected joints, thus reducing joint's functionality. Therefore a treatment that would reduce pain/stiffness and increase joint function would be of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in few clinical studies.
This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to determine safety and efficacy of a single injection of freshly isolated autologous SVFs into the knees of osteoarthritic patients (Grade II-III). In experimental group the participants (n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue will be processed to obtain the SVFs and patients will receive a single intra-articular injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel control group the participants (n=11) will receive a single intra-articular injection of hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs injection will be evaluated by assessment of the frequency and nature of adverse events occurring during or immediately after the procedure, and up to the one year following treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular auto-SVFs injection | Experimental | Procedure: Intra-articular auto-SVFs injectionThe participants will undergo a standard liposuction to harvest adipose tissue. The adipose tissue will then be processed to obtain the SVFs. This group of subjects (n=16) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint). |
| Intra-articular Hyaluronic Acid | Active comparator | Drug: Hyaluronic AcidThis group of subjects (n=11) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40 to 85 Years (Adult, Senior)
- Grade II or Grade III osteoarthritis of the knee joints using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray and physician review, and/or MRI
- Patients must have continued pain in the knee despite conservative therapies for at least 3 months
- Patients must be able to tolerate all study procedures
- Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
Key exclusion criteria (12 listed)
- Subjects with a BMI > 35
- Subjects who have had an injection in either knee in the prior 4 weeks, including corticosteroids, drugs of hyaluronic acid or platelet rich plasma (PRP).
- Subjects who have had surgery of either knee within 6 months prior to the screening visit
- Subjects those are allergic to drugs for local anesthesia
- Psychiatric disorders
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 |
|---|---|---|
| Intra-articular auto-SVFs injectionLiposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation | Procedure or surgery | Intra-articular auto-SVFs injection |
| Hyaluronic AcidAlso: Synocrom ForteSingle intra-articular injection of Synocrom Forte 2% under the ultrasound navigation | Drug | Intra-articular Hyaluronic Acid |
Primary outcome
The number of patients with adverse events
Time frame: up to 12 months after treatment
The safety of intra-articular injection of auto-SVFs will be evaluated by assessment of the frequency and nature of adverse events during or immediately after the procedure, and up to the 12-months following treatment
3 secondary outcomes
Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits
Time frame: Baseline, 1, 3, 6 and 12 months after treatment
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits
Time frame: Baseline, 1, 3, 6 and 12 months after treatment
Change in Ultrasonography of the knee joints
Time frame: Baseline, 3, 6 and 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 25706817Michalek J, Moster R, Lukac L, Proefrock K, Petrasovic M, Rybar J, Capkova M, Chaloupka A, Darinskas A, Michalek J Sr, Kristek J, Travnik J, Jabandziev P, Cibulka M, Holek M, Jurik M, Skopalik J, Kristkova Z, Dudasova Z. WITHDRAWN: Autologous adipose tissue-derived stromal vascular fraction cells application in patients with osteoarthritis. Cell Transplant. 2015 Jan 20. doi: 10.3727/096368915X686760. Online ahead of print.
- BackgroundGarza GR, Palomera T, Dumanian GA, Dos-Anjos S. Use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of the knee: a feasibility and safety study. J Regen Med. 4(1), 2015 doi:10.4172/2325-9620.1000119
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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.
Elena R Chernykh, MD, PhD study chair
Institute of Fundamental and Clinical Immunology
Alexander A Ostanin, MD, PhD principal investigator
Institute of Fundamental and Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intra-articular auto-SVFs injection and Hyaluronic Acid in people with Osteoarthritis and Joint Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with adverse events (time frame: up to 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967874, which also lists 2 linked publications.
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 13 Sep 2019.