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

Primary Purpose

Osteo Arthritis Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Injection of Autologous Adipose Tissue

Injection of lactated ringers

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Osteo Arthritis Knee, Autologous Adipose Tissue

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Aestique Ambulatory Surgical Center
DNA Advanced Pain Treatment

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Injection of Autologous Adipose Tissue

Injection of Lactated Ringers

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety - Incidence of Treatment-Emergent Adverse Events

Subjects will be monitored for adverse events

Secondary Outcome Measures

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

Patient outcomes for pain will be recorded

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

Patient outcomes for function will be recorded

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

Patient outcomes for stiffness will be recorded

Full Information

NCT ID

NCT03399630

First Posted

October 11, 2017

Last Updated

June 25, 2018

Sponsor

Aestique Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03399630

Brief Title

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

Official Title

Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 9, 2016 (Actual)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aestique Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee

Keywords

Osteo Arthritis Knee, Autologous Adipose Tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double blind parallel groups assignment

Masking

ParticipantCare Provider

Masking Description

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

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Injection of Autologous Adipose Tissue

Arm Type

Active Comparator

Arm Description

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

Arm Title

Injection of Lactated Ringers

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Injection of Autologous Adipose Tissue

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Injection of lactated ringers

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety - Incidence of Treatment-Emergent Adverse Events

Description

Subjects will be monitored for adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Patient outcomes for pain will be recorded

Time Frame

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

Title

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

Description

Patient outcomes for function will be recorded

Time Frame

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

Title

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

Description

Patient outcomes for stiffness will be recorded

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

Patient outcomes for pain will be recorded

Time Frame

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

Title

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

Description

Patient outcomes for function will be recorded

Time Frame

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

Title

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

Description

Patient outcomes for stiffness will be recorded

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Theodore Lazzaro, MD

Organizational Affiliation

Aestique Ambulatory Surgical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aestique Ambulatory Surgical Center

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

Facility Name

DNA Advanced Pain Treatment

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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