Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee

NCT03399630 | Completed

• 1 other identifier: ATOA-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.

Conditions

Osteo Arthritis Knee

Keywords

Osteo Arthritis Knee; Autologous Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• Safety - Incidence of Treatment-Emergent Adverse Events

  Subjects will be monitored for adverse events

  6 months

Secondary Outcomes (3)

• Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

• Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

• Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

Other Outcomes (3)

• Efficacy - Change in Pain Scores on the VAS Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

• Efficacy - Change in Function Scores on the VAS Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

• Efficacy - Change in Stiffness Scores on the VAS Scale at All Follow-Up Visits

  1 week, 6 weeks, 3 months, and 6 months

Study Arms (2)

Injection of Autologous Adipose Tissue

ACTIVE COMPARATOR

Treatment knee receives injection of 1.5 cc's of adipose tissue mixed with 1.5 cc's of Lactated Ringers

Other: Injection of Autologous Adipose Tissue

Injection of Lactated Ringers

PLACEBO COMPARATOR

Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue

Other: Injection of lactated ringers

Interventions

Injection of Autologous Adipose Tissue OTHER

Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis

Injection of Autologous Adipose Tissue

Injection of lactated ringers OTHER

Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

Injection of Lactated Ringers

Eligibility Criteria

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

You may qualify if:

• Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
• Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
• Males and females 40-75 years old.
• Participants will be in good health (ASA Class I-II) with a BMI \< 35.
• Continued pain in the knee despite conservative therapies for at least 6 months.
• Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
• Must speak, read and understand English.
• Subjects must be reasonably able to return for multiple follow-up visits.

You may not qualify if:

• Participants who have had surgery of either knee within 6 months prior to the screening visit.
• Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
• Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
• Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
• Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
• Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
• Participants that are allergic to lidocaine, epinephrine or valium
• History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
• Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months

Sponsors & Collaborators

• Aestique Medical Center: lead

Study Sites (2)

Aestique Ambulatory Surgical Center

Greensburg, Pennsylvania, 15601, United States

Location

DNA Advanced Pain Treatment

Greensburg, Pennsylvania, 15601, United States

Location

Study Officials

• Theodore Lazzaro, MD

  Aestique Ambulatory Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient and treating physician are both blinded, being that neither are aware of which knee received the autologous adipose tissue injection and which knee received the placebo lactated ringers injection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind parallel groups assignment

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: January 16, 2018
• Study Start: August 9, 2016
• Primary Completion: February 28, 2018
• Study Completion: May 31, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)