Osteoarthritis, KneeNCT06562101
Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees
A study testing Intra-articular Stromal Vascular Fraction Injection in people with Osteoarthritis, Knee, run by Shu-Hao Chang, MD at 1 site in Taiwan.
Trial summary
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intra-articular Stromal Vascular Fraction Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2020to 30 Jun 2022
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 35 years.
- Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2~4.
- Persistent knee pain after nonsurgical treatment.
Who cannot join
- Arthritis caused by other systemic or local immune diseases.
- Patients who have undergone total knee replacement surgery.
- Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
- Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
- Patients with severe heart problems and coagulation disorders.
- Patients who have taken glucosamine within the previous month.
- MRI exclusion conditions, including patients with a heart rhythm regulator who have received vascular surgery with a hemostatic clip and artificial heart valves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intra-articular Stromal Vascular Fraction Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular Stromal Vascular Fraction InjectionProcedure or surgery
Also called Stromal Vascular Fraction therapy
Adipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions.
| Study group | Role | What they receive |
|---|---|---|
| Stromal Vascular Fraction (SVF) | Experimental | Ten patients with knee OA were administered intra-articular SVF injections. Receives: Procedure: Intra-articular Stromal Vascular Fraction Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
range from 0-96, with higher scores indicating greater OA-related disability
Measured: Baseline and at 3 and 6 months post-intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS)
5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA
Measured: Baseline and at 3 and 6 months post-intervention
Visual Analogue Scale (VAS)
range from 0-10, with higher scores indicating increased degree of pain
Measured: Baseline and at 3 and 6 months post-intervention
Magnetic resonance imaging (MRI)
included T2 mapping
Measured: Baseline and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start4 Dec 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shu-Hao Chang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Hao Chang, MD, Fu Jen Catholic University Hospital
- Investigators
- Shu-Hao Chang, MD, Principal investigator, Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562101
- Sponsor's protocol ID
- FJUH109069
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abramoff B, Caldera FE. Osteoarthritis: Pathology, Diagnosis, and Treatment Options. Med Clin North Am. 2020 Mar;104(2):293-311. doi: 10.1016/j.mcna.2019.10.007. Epub 2019 Dec 18.
PubMed 32035570Lin FH, Chen HC, Lin C, Chiu YL, Lee HS, Chang H, Huang GS, Chang HL, Yeh SJ, Su W, Wang CC, Su SL. The increase in total knee replacement surgery in Taiwan: A 15-year retrospective study. Medicine (Baltimore). 2018 Aug;97(31):e11749. doi: 10.1097/MD.0000000000011749.
PubMed 30075592Taruc-Uy RL, Lynch SA. Diagnosis and treatment of osteoarthritis. Prim Care. 2013 Dec;40(4):821-36, vii. doi: 10.1016/j.pop.2013.08.003. Epub 2013 Sep 26.
PubMed 24209720Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
PubMed 32109160Coughlin RP, Oldweiler A, Mickelson DT, Moorman CT 3rd. Adipose-Derived Stem Cell Transplant Technique for Degenerative Joint Disease. Arthrosc Tech. 2017 Oct 2;6(5):e1761-e1766. doi: 10.1016/j.eats.2017.06.048. eCollection 2017 Oct.
PubMed 29399463Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
PubMed 27565858Lindroos B, Suuronen R, Miettinen S. The potential of adipose stem cells in regenerative medicine. Stem Cell Rev Rep. 2011 Jun;7(2):269-91. doi: 10.1007/s12015-010-9193-7.
PubMed 20853072Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.
PubMed 15374852Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.
PubMed 17013996Xia B, Di Chen, Zhang J, Hu S, Jin H, Tong P. Osteoarthritis pathogenesis: a review of molecular mechanisms. Calcif Tissue Int. 2014 Dec;95(6):495-505. doi: 10.1007/s00223-014-9917-9. Epub 2014 Oct 14.
PubMed 25311420Krasnokutsky S, Samuels J, Abramson SB. Osteoarthritis in 2007. Bull NYU Hosp Jt Dis. 2007;65(3):222-8.
PubMed 17922674Anil U, Markus DH, Hurley ET, Manjunath AK, Alaia MJ, Campbell KA, Jazrawi LM, Strauss EJ. The efficacy of intra-articular injections in the treatment of knee osteoarthritis: A network meta-analysis of randomized controlled trials. Knee. 2021 Oct;32:173-182. doi: 10.1016/j.knee.2021.08.008. Epub 2021 Sep 6.
PubMed 34500430Aletto C, Giordano L, Quaranta M, Zara A, Notarfrancesco D, Maffulli N. Short-term results of intra-articular injections of stromal vascular fraction for early knee osteoarthritis. J Orthop Surg Res. 2022 Jun 11;17(1):310. doi: 10.1186/s13018-022-03196-0.
PubMed 35690837Friedrich KM, Shepard T, de Oliveira VS, Wang L, Babb JS, Schweitzer M, Regatte R. T2 measurements of cartilage in osteoarthritis patients with meniscal tears. AJR Am J Roentgenol. 2009 Nov;193(5):W411-5. doi: 10.2214/AJR.08.2256.
PubMed 19843720Zhang Y, Bi Q, Luo J, Tong Y, Yu T, Zhang Q. The Effect of Autologous Adipose-Derived Stromal Vascular Fractions on Cartilage Regeneration Was Quantitatively Evaluated Based on the 3D-FS-SPGR Sequence: A Clinical Trial Study. Biomed Res Int. 2022 Jan 25;2022:2777568. doi: 10.1155/2022/2777568. eCollection 2022.
PubMed 35118156
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intra-articular Stromal Vascular Fraction Injection on Clinical Symptoms and Cartilage Health in Osteoarthritic Knees: A Single-Center Pilot Study
- ClinicalTrials.gov ID
- NCT06562101
- Acronym / sponsor ID
- FJUH109069
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shu-Hao Chang, MDUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Aug 2024 (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.
Background: Osteoarthritis (OA) is a prevalent form of arthritis worldwide. Intra-articular stromal vascular fraction (SVF) injections are a potential therapeutic option for patients with OA. This study aims to assess the effects of intra-articular SVF injections on knee OA. Methods: Ten patients with knee OA participated in this study. After being administered intra-articular SVF injections, their outcomes were evaluated using various questionnaires. MRI T2 mapping was conducted and compared before the intervention and 6 months after. All data underwent analysis using various tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stromal Vascular Fraction (SVF) | Experimental | Procedure: Intra-articular Stromal Vascular Fraction InjectionTen patients with knee OA were administered intra-articular SVF injections. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 35 years.
- Patients with degenerative knee OA confirmed via X-ray and classified according to the Kellgren Lawrence Grading Scale 2~4.
- Persistent knee pain after nonsurgical treatment.
Key exclusion criteria (7 listed)
- Arthritis caused by other systemic or local immune diseases.
- Patients who have undergone total knee replacement surgery.
- Patients who have been administered platelet-rich plasma or hyaluronic acid injections within the past three months.
- Patients with symptoms related to degenerative arthritis in the ankle, which affected the assessment of pain.
- Patients with severe heart problems and coagulation 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 Stromal Vascular Fraction InjectionAlso: Stromal Vascular Fraction therapyAdipose tissue was harvested using the Q-graft system (Human Med®) from the abdominal subcutaneous fat of patients under local anesthesia. After concentration and resuspension in normal saline, 5 mL of the SVF suspension was injected into the knee joint cavity under sterile conditions. | Procedure or surgery | Stromal Vascular Fraction (SVF) |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline and at 3 and 6 months post-intervention
range from 0-96, with higher scores indicating greater OA-related disability
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline and at 3 and 6 months post-intervention
5 items, ranging from 0-96, with higher scores indicating worse life quality related to OA
Visual Analogue Scale (VAS)
Time frame: Baseline and at 3 and 6 months post-intervention
range from 0-10, with higher scores indicating increased degree of pain
Magnetic resonance imaging (MRI)
Time frame: Baseline and 6 months after the intervention
included T2 mapping
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 20 Aug 2024.
- Background: PubMed 32035570Abramoff B, Caldera FE. Osteoarthritis: Pathology, Diagnosis, and Treatment Options. Med Clin North Am. 2020 Mar;104(2):293-311. doi: 10.1016/j.mcna.2019.10.007. Epub 2019 Dec 18.
- Background: PubMed 30075592Lin FH, Chen HC, Lin C, Chiu YL, Lee HS, Chang H, Huang GS, Chang HL, Yeh SJ, Su W, Wang CC, Su SL. The increase in total knee replacement surgery in Taiwan: A 15-year retrospective study. Medicine (Baltimore). 2018 Aug;97(31):e11749. doi: 10.1097/MD.0000000000011749.
- Background: PubMed 24209720Taruc-Uy RL, Lynch SA. Diagnosis and treatment of osteoarthritis. Prim Care. 2013 Dec;40(4):821-36, vii. doi: 10.1016/j.pop.2013.08.003. Epub 2013 Sep 26.
- Background: PubMed 32109160Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.
- Background: PubMed 29399463Coughlin RP, Oldweiler A, Mickelson DT, Moorman CT 3rd. Adipose-Derived Stem Cell Transplant Technique for Degenerative Joint Disease. Arthrosc Tech. 2017 Oct 2;6(5):e1761-e1766. doi: 10.1016/j.eats.2017.06.048. eCollection 2017 Oct.
- Background: PubMed 27565858Lamo-Espinosa JM, Mora G, Blanco JF, Granero-Molto F, Nunez-Cordoba JM, Sanchez-Echenique C, Bondia JM, Aquerreta JD, Andreu EJ, Ornilla E, Villaron EM, Valenti-Azcarate A, Sanchez-Guijo F, Del Canizo MC, Valenti-Nin JR, Prosper F. Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II). J Transl Med. 2016 Aug 26;14(1):246. doi: 10.1186/s12967-016-0998-2.
- Background: PubMed 20853072Lindroos B, Suuronen R, Miettinen S. The potential of adipose stem cells in regenerative medicine. Stem Cell Rev Rep. 2011 Jun;7(2):269-91. doi: 10.1007/s12015-010-9193-7.
- Background: PubMed 15374852Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.
- Background: PubMed 17013996Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.
- Background: PubMed 25311420Xia B, Di Chen, Zhang J, Hu S, Jin H, Tong P. Osteoarthritis pathogenesis: a review of molecular mechanisms. Calcif Tissue Int. 2014 Dec;95(6):495-505. doi: 10.1007/s00223-014-9917-9. Epub 2014 Oct 14.
- Background: PubMed 17922674Krasnokutsky S, Samuels J, Abramson SB. Osteoarthritis in 2007. Bull NYU Hosp Jt Dis. 2007;65(3):222-8.
- Background: PubMed 34500430Anil U, Markus DH, Hurley ET, Manjunath AK, Alaia MJ, Campbell KA, Jazrawi LM, Strauss EJ. The efficacy of intra-articular injections in the treatment of knee osteoarthritis: A network meta-analysis of randomized controlled trials. Knee. 2021 Oct;32:173-182. doi: 10.1016/j.knee.2021.08.008. Epub 2021 Sep 6.
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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.
Shu-Hao Chang, MD principal investigator
Department of Orthopedics, Fu Jen Catholic University Hospital, Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular Stromal Vascular Fraction Injection in people with Osteoarthritis, Knee, run by Shu-Hao Chang, MD at 1 site in Taiwan.
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 3 inclusion and 7 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 20 Aug 2024. 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 Taiwan. 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.
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Baseline and at 3 and 6 months post-intervention). The study lists 4 primary outcomes in all. 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 NCT06562101, which also lists 15 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 20 Aug 2024.