Knee Osteoarthritis With Stromal Vascular Fraction Cells

NCT ID: NCT07259993

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-27
• Study Completion Date: 2025-10-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SVF cells treatment

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

Group Type: EXPERIMENTAL

autologous adipose tissue-derived stromal vascular fraction cells

Intervention Type: BIOLOGICAL

SVF cells via intra-articular injection into knees

Interventions

autologous adipose tissue-derived stromal vascular fraction cells

SVF cells via intra-articular injection into knees

Intervention Type: BIOLOGICAL

Other Intervention Names

SVF

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: collaborator

Ministry of Health Nicaragua

UNKNOWN

Sponsor Role: collaborator

Hospital Vivian Pellas, Nicaragua

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Michael H Carstens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Escuela Oscar Danilo Rosales Arguello

León, , Nicaragua

Countries

Nicaragua

References

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.

Reference Type: BACKGROUND

PMID: 37678972 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36545894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26238455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39658493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28148295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32722615 (View on PubMed)

Other Identifiers

MS-DGRS-MABJ-7536-11-13

Identifier Type: -

Identifier Source: org_study_id