NCT07259993

Brief 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. Later, subjects were followed for safety out and potential benefits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2013

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

11.9 years

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment related adverse events

    Documentation of adverse events

    6 months follow-up post intervention

  • Osteoarthritis outcome score (KOOS)

    Changes in KOOS scores

    Up to 10 years follow-up post SVF treatment

Study Arms (1)

SVF cells treatment

EXPERIMENTAL

Intra-articular injection of SVF cells in the injured knee.

Biological: autologous adipose tissue-derived stromal vascular fraction cells

Interventions

autologous adipose tissue-derived stromal vascular fraction cellsBIOLOGICAL

SVF cells via intra-articular injection into knees

Also known as: SVF
SVF cells treatment

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Corticosteroid injection within 3 months prior to SVF treatment
  • Taking anticoagulants prior to SVF treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Escuela Oscar Danilo Rosales Arguello

León, Nicaragua

Location

Related Publications (6)

  • 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.

    PMID: 28148295BACKGROUND

  • Primorac 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.

    PMID: 32722615BACKGROUND

  • Gao 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.

    PMID: 37678972BACKGROUND

  • Carstens 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.

    PMID: 36545894BACKGROUND

  • Fodor 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.

    PMID: 26238455BACKGROUND

  • Carstens 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.

    PMID: 39658493BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

August 27, 2013

Primary Completion

July 26, 2025

Study Completion

October 30, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

NI(1)