Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-08-30

Brief Summary

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This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.

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Detailed Description

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This study is a prospective, multi center randomized double blind, two arm study.

90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Autologous Conditioned Plasma (ACP)

3 Intra-articular (IA) injections at 1 week intervals

Group Type EXPERIMENTAL

ACP

Intervention Type DEVICE

Autologous Conditioned Plasma

Normal Saline (NS)

3 NS Intra-articular (IA) injections at 1 week intervals

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Three Normal Saline IA injections of 3-8 mL at 1-week intervals.

Interventions

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ACP

Autologous Conditioned Plasma

Intervention Type DEVICE

Placebo

Three Normal Saline IA injections of 3-8 mL at 1-week intervals.

Intervention Type OTHER

Other Intervention Names

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Normal Saline

Eligibility Criteria

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Inclusion Criteria

1. The subject is 18 to 70 years of age.
2. The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
3. The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
4. The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities

Exclusion Criteria

1. Grade I and IV on the knee Kellgren-Lawrence grading scale
2. Subject has clinically 3+ effusion of the target knee (stroke test grading system).
3. Subject has significant (\> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
4. Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
5. Viscosupplementation in any joint in the past six months.
6. Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
7. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
8. Subject has inflammatory disease of either knee other than OA.
9. Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
10. Subject with positive pregnancy test, or breast feeding.
11. Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
12. Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subject has rheumatoid arthritis or gout
14. Subject has a history of or a current infection at the affected joint.
15. Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
16. Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes