Knee Osteoarthritis With Stromal Vascular Fraction Cells

Treatment of Knee Osteoarthritis With Stromal Vascular Fraction Cells: 10-Years Follow-up

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07259993

Enrollment

Registered

2025-12-02

Start date

2013-08-27

Completion date

2025-10-30

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

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.

Interventions

BIOLOGICALautologous adipose tissue-derived stromal vascular fraction cells

SVF cells via intra-articular injection into knees

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment related adverse events	6 months follow-up post intervention	Documentation of adverse events
Osteoarthritis outcome score (KOOS)	Up to 10 years follow-up post SVF treatment	Changes in KOOS scores

Countries

Nicaragua

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026