Knee Osteoarthritis With Stromal Vascular Fraction Cells

Michael H Carstens

Status and phase: Completed; Phase 2; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Biological: autologous adipose tissue-derived stromal vascular fraction cells

Study type: Interventional

Funder types: Other

Identifiers

NCT07259993

MS-DGRS-MABJ-7536-11-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

SVF cells treatment

Experimental group

Description:

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

Treatment:

Biological: autologous adipose tissue-derived stromal vascular fraction cells