Knee OsteoarthritisPhase 1/2NCT07259993
Knee Osteoarthritis With Stromal Vascular Fraction Cells
A Phase 1/2 study testing autologous adipose tissue-derived stromal vascular fraction cells in people with Knee Osteoarthritis, run by Michael H Carstens at 1 site in Nicaragua.
Trial summary
This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- autologous adipose tissue-derived stromal vascular fraction cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNicaragua
- Study dates
- 27 Aug 2013to 30 Oct 2025
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically documented Kellgren Lawence grade 3 (moderate) KOA;
- Knee pain rated greater than 4/10 on the linear pain scale;
- Previous treatment history with anti-inflammatory medications or corticosteroid injections
Who cannot join
- Corticosteroid injection within 3 months prior to SVF treatment
- Taking anticoagulants prior to SVF treatment
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Hospital Escuela Oscar Danilo Rosales Arguello
León
About this study
Official title: Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up
This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Later, subjects were followed for safety out and potential benefits.
Read the detailed description
A prospective, open-label interventional study was conducted to assess safety and evidence of clinical response to administration of intra-articular SVF in 16 patients with symptomatic, radiographic Kellgren Lawence grade 3 KOA. Approximately 55.5 million SVF cells were administered via intra-articular injection into each of the 29 knees; asymptomatic knees remained untreated. Subjects were followed for safety out to six months. Potential benefit was measured using the Knee Injury Osteoarthritis Outcome Scores (KOOS) at baseline (pre-treatment), at 3- and 6-months post-treatment, and then subsequently at 10 years.
- Conditions
- Knee Osteoarthritis
- Being tested
- autologous adipose tissue-derived stromal vascular fraction cells
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose tissue-derived stromal vascular fraction cellsBiological
Also called SVF
SVF cells via intra-articular injection into knees
| Study group | Role | What they receive |
|---|---|---|
| SVF cells treatment | Experimental | Intra-articular injection of SVF cells in the injured knee. Receives: Biological: autologous adipose tissue-derived stromal vascular fraction cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events
Documentation of adverse events
Measured: 6 months follow-up post intervention
Osteoarthritis outcome score (KOOS)
Changes in KOOS scores
Measured: Up to 10 years follow-up post SVF treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start27 Aug 2013
- Primary completion26 Jul 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael H Carstens
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, Ministry of Health Nicaragua, Hospital Vivian Pellas, Nicaragua, University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259993
- Sponsor's protocol ID
- MS-DGRS-MABJ-7536-11-13
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mathiessen A, Conaghan PG. Synovitis in osteoarthritis: current understanding with therapeutic implications. Arthritis Res Ther. 2017 Feb 2;19(1):18. doi: 10.1186/s13075-017-1229-9.
PubMed 28148295Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.
PubMed 32722615Gao F, Mao X, Wu X. Mesenchymal stem cells in osteoarthritis: The need for translation into clinical therapy. Prog Mol Biol Transl Sci. 2023;199:199-225. doi: 10.1016/bs.pmbts.2023.02.006. Epub 2023 Mar 16.
PubMed 37678972Carstens MH, Garcia N, Mandayam S, Workeneh B, Pastora I, Calderon C, Bertram KA, Correa D. Safety of Stromal Vascular Fraction Cell Therapy for Chronic Kidney Disease of Unknown Cause (Mesoamerican Nephropathy). Stem Cells Transl Med. 2023 Jan 30;12(1):7-16. doi: 10.1093/stcltm/szac080.
PubMed 36545894Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3.
PubMed 26238455Carstens M, Martinez-Cerrato J, Garcia L, Rivera B, Bertram K. Safety of adipose-derived stromal vascular fraction cells to treat Parkinson's disease. Parkinsonism Relat Disord. 2025 Mar;132:107214. doi: 10.1016/j.parkreldis.2024.107214. Epub 2024 Nov 28.
PubMed 39658493
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up
- ClinicalTrials.gov ID
- NCT07259993
- Acronym / sponsor ID
- MS-DGRS-MABJ-7536-11-13
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Michael H CarstensUniversity, hospital or other
- Collaborators
- Wake Forest University, Ministry of Health Nicaragua, Hospital Vivian Pellas, Nicaragua, University of California, San Francisco
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 26 Jul 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 2 Dec 2025 (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.
This is an interventional study to treat knees osteoarthritis (KOA) with adipose-derived stromal vascular fraction cell components in sixteen subjects with either unilateral or bilateral symptomatic Kellgren Lawence Grade 3 KOA by intra-articular injection of knees. Later, subjects were followed for safety out and potential benefits.
Detailed description
A prospective, open-label interventional study was conducted to assess safety and evidence of clinical response to administration of intra-articular SVF in 16 patients with symptomatic, radiographic Kellgren Lawence grade 3 KOA. Approximately 55.5 million SVF cells were administered via intra-articular injection into each of the 29 knees; asymptomatic knees remained untreated. Subjects were followed for safety out to six months. Potential benefit was measured using the Knee Injury Osteoarthritis Outcome Scores (KOOS) at baseline (pre-treatment), at 3- and 6-months post-treatment, and then subsequently at 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVF cells treatment | Experimental | Biological: autologous adipose tissue-derived stromal vascular fraction cellsIntra-articular injection of SVF cells in the injured knee. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiologically documented Kellgren Lawence grade 3 (moderate) KOA;
- Knee pain rated greater than 4/10 on the linear pain scale;
- Previous treatment history with anti-inflammatory medications or corticosteroid injections
Key exclusion criteria (2 listed)
- Corticosteroid injection within 3 months prior to SVF treatment
- Taking anticoagulants prior to SVF treatment
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 |
|---|---|---|
| autologous adipose tissue-derived stromal vascular fraction cellsAlso: SVFSVF cells via intra-articular injection into knees | Biological | SVF cells treatment |
Primary outcome
Incidence of treatment related adverse events
Time frame: 6 months follow-up post intervention
Documentation of adverse events
Osteoarthritis outcome score (KOOS)
Time frame: Up to 10 years follow-up post SVF treatment
Changes in KOOS scores
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 2 Dec 2025.
- Background: PubMed 28148295Mathiessen A, Conaghan PG. Synovitis in osteoarthritis: current understanding with therapeutic implications. Arthritis Res Ther. 2017 Feb 2;19(1):18. doi: 10.1186/s13075-017-1229-9.
- Background: PubMed 32722615Primorac D, Molnar V, Rod E, Jelec Z, Cukelj F, Matisic V, Vrdoljak T, Hudetz D, Hajsok H, Boric I. Knee Osteoarthritis: A Review of Pathogenesis and State-Of-The-Art Non-Operative Therapeutic Considerations. Genes (Basel). 2020 Jul 26;11(8):854. doi: 10.3390/genes11080854.
- Background: PubMed 37678972Gao F, Mao X, Wu X. Mesenchymal stem cells in osteoarthritis: The need for translation into clinical therapy. Prog Mol Biol Transl Sci. 2023;199:199-225. doi: 10.1016/bs.pmbts.2023.02.006. Epub 2023 Mar 16.
- Background: PubMed 36545894Carstens MH, Garcia N, Mandayam S, Workeneh B, Pastora I, Calderon C, Bertram KA, Correa D. Safety of Stromal Vascular Fraction Cell Therapy for Chronic Kidney Disease of Unknown Cause (Mesoamerican Nephropathy). Stem Cells Transl Med. 2023 Jan 30;12(1):7-16. doi: 10.1093/stcltm/szac080.
- Background: PubMed 26238455Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3.
- Background: PubMed 39658493Carstens M, Martinez-Cerrato J, Garcia L, Rivera B, Bertram K. Safety of adipose-derived stromal vascular fraction cells to treat Parkinson's disease. Parkinsonism Relat Disord. 2025 Mar;132:107214. doi: 10.1016/j.parkreldis.2024.107214. Epub 2024 Nov 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 autologous adipose tissue-derived stromal vascular fraction cells in people with Knee Osteoarthritis, run by Michael H Carstens at 1 site in Nicaragua.
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 2 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 2 Dec 2025. 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 Nicaragua. 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?
Incidence of treatment related adverse events (time frame: 6 months follow-up post intervention). 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?
On the ClinicalTrials.gov record for NCT07259993, which also lists 6 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 2 Dec 2025.