Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee

NCT03940950 | Completed Phase 1 FDA Drug

• 1 other identifier: 18-006909
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis

Conditions

Osteo Arthritis Knee; Degenerative Joint Disease of Knee

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of adverse events reported

  2 years

Study Arms (2)

SVF (Stromal Vascular Fraction) Group

EXPERIMENTAL

Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells

Biological: Autologous Adipose-Derived SVF (Stromal Vascular Fraction)

Placebo Group

PLACEBO COMPARATOR

Subjects with knee osteoarthritis (OA) will be treated with a placebo

Drug: Placebo

Interventions

Autologous Adipose-Derived SVF (Stromal Vascular Fraction) BIOLOGICAL

60 ml of fat is collected from subjects abdominal wall and SVF is removed from the fat. The SVF is injected into the knee through a needle.

SVF (Stromal Vascular Fraction) Group

Placebo DRUG

Saline control that contains no active ingredient

Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 40-75 years
• Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
• Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded. Radiographic assessment will be deferred if the patient becomes pregnant.
• Radiographic medial and/or lateral femorotibial knee OA Kellgren-Lawrence grade 2 or 3 accompanied by definite joint space narrowing as agreed upon by two study coinvestigators. If no agreement, a musculoskeletal radiologist not associated with the study will make the final grading.
• Previous 3 month or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone, hyaluronic acid/viscosupplement).
• Able to routinely walk without assistance (e.g. cane, walker).
• Clinically stable target knee.
• Completed general physical evaluation with primary care provider within 12 months of enrollment.
• Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, repeated knee injections/aspirations, arthroscopic examination and follow-up visits and assessments.
• Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure.
• Subjects taking medications for symptomatic relief of OA under the supervision of their primary caregiver, including non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) may continue to take these medications unless they are otherwise excluded by the protocol and as long as the dosing has been stable for 4 weeks before baseline and is anticipated to remain stable until at least 30 days following completion of the subject's treatment cycle.

You may not qualify if:

• Pregnant or nursing, or planning on becoming pregnant during the study period.
• Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results.
• Significant clinical malalignment requiring follow-up full length, standing X-rays.
• Orthopedic hardware or implantable devices anywhere in the body, other than dental.
• Surgery on the index knee within 1 year of study enrollment.
• Injections of any into the index knee within 3 months prior to study enrollment.
• Locking, catching, give-away or another major mechanical symptom of the target knee.
• Kellgren-Lawrence Grade 1 or-4 arthritis in the index knee.
• History of intra-articular infection in the index knee.
• History of superficial infection in the index knee within 6 months of study enrollment, or evidence of current superficial infection affecting the index knee.
• History of falls requiring medical attention, or gait instability.
• Body mass index (BMI) \> 40 kg/m2.
• Taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix).
• Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin).
• Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shane A Shapiro

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: July 2, 2019
• Primary Completion: May 5, 2025
• Study Completion: May 23, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)