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Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03889925
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Brief Summary:
The clinical efficacy of hyaluronic acid or corticosteroid injections has been reported, but effects are short lived. This has led to the development of additional injection options such as autologous derived blood products which have been documented to alleviate symptoms related to knee osteoarthritis, with recent comparative studies suggesting a greater, long-lasting effect with these blood derived products like platelet rich plasma (PRP) [2-8]. One clinically-developed preparation of platelet rich plasma, named autologous conditioned plasma (ACP), has randomized controlled trial data proving efficacy [4,9]. Clinical use of platelet rich plasma for knee arthritis typically involves a 3-injection series over 3 weeks, i.e. an injection once a week for three weeks. The main objective of this study is to determine if hyaluronic acid (HA) injected at the same time as autologous conditioned plasma (ACP), a leukocyte-poor platelet rich plasma product, will improve the performance of ACP in the treatment of symptomatic knee osteoarthritis. It is hypothesized that the injection of hyaluronic acid will improve the efficacy of ACP.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Hymovis Biological: Autologous conditioned plasma Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants will be blinded to the type of injection that they receive.
Primary Purpose: Treatment
Official Title: Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous conditioned plasma group
Participants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks.
Biological: Autologous conditioned plasma
Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.

Experimental: Autologous conditioned plasma with hyaluronic acid group
Participants in this group will receive a two-injection series of autologous conditioned plasma and hyaluronic acid (Hymovis, Fidia Pharmaceuticals) and a third injection on the third week of autologous conditioned plasma.
Drug: Hymovis
Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.




Primary Outcome Measures :
  1. Change in Western Ontario and McMaster University's Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]
    Patient reported outcome measure; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total score. Higher scores indicate worse pain, stiffness, and functional limitations.

  2. Change in International Knee Documentation Committee Subjective Knee Evaluation Form [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]
    Patient reported outcome measure; Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.

  3. Change in Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections ]
    Patient reported outcome measure; Consists of 5 subscales; Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life. each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 30 and 80
  • Documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the involved knee (Kellgren-Lawrence grades 1-4)
  • Patients must have a documented diagnosis of primary OA for at least 6 weeks.

Exclusion Criteria:

  • Patients who have had viscosupplementation in the involved knee in the past 6 months.
  • Any patient who has had a corticosteroid injection in any joint within 3-months prior to screening will be excluded.
  • Patients with gout or rheumatologic disease will be excluded. Patients who have had a previous negative experience with HA.
  • Any patient who will have difficulty obtaining internet access, does not have an active e-mail address, or is unable to comprehend study documents or give informed consent will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889925


Locations
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United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, United States, 32561
Sponsors and Collaborators
Andrews Research & Education Foundation
  Study Documents (Full-Text)

Documents provided by Andrews Research & Education Foundation:
Informed Consent Form  [PDF] June 27, 2019

Publications:

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Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03889925    
Other Study ID Numbers: 1379083
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases