Knee Osteoarthritis With Stromal Vascular Fraction Cells

November 21, 2025 updated by: Michael H Carstens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nicaragua
      • León, Nicaragua
        • Hospital Escuela Oscar Danilo Rosales Argüello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SVF cells treatment
Intra-articular injection of SVF cells in the injured knee.
Biological: autologous adipose tissue-derived stromal vascular fraction cells
SVF cells via intra-articular injection into knees
Other Names:
  • SVF

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael H Carstens

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2013

Primary Completion (Actual)

July 26, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-DGRS-MABJ-7536-11-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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