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Completed

NCT Number: NCT07259993

Knee Osteoarthritis With Stromal Vascular Fraction Cells

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Escuela Oscar Danilo Rosales Arguello

León, Nicaragua

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous adipose tissue-derived stromal vascular fraction cells

Biological

SVF cells via intra-articular injection into knees

Other names: SVF

Primary outcomes

  1. Incidence of treatment related adverse events

    Time frame: 6 months follow-up post intervention

    Documentation of adverse events

  2. Osteoarthritis outcome score (KOOS)

    Time frame: Up to 10 years follow-up post SVF treatment

    Changes in KOOS scores

Sponsors and collaborators

Lead sponsor

Michael H Carstens

Other

Collaborators

  • Hospital Vivian Pellas, Nicaragua
  • Ministry of Health Nicaragua
  • University of California, San Francisco
  • Wake Forest University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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