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

NCT03889925 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1379083
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Western Ontario and McMaster University's Osteoarthritis Index (WOMAC)

  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.

  Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections

• International Knee Documentation Committee Subjective Knee Evaluation Form

  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.

  Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections

• Knee Injury and Osteoarthritis Outcome Score

  Patient reported outcome measure; A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.

  Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections

Study Arms (2)

Autologous conditioned plasma group

EXPERIMENTAL

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

Autologous conditioned plasma with hyaluronic acid group

EXPERIMENTAL

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: Hyaluronan

Interventions

Hyaluronan DRUG

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.

Also known as: Hymovis, Monovisc, Orthovisc

Autologous conditioned plasma with hyaluronic acid group

Autologous conditioned plasma BIOLOGICAL

Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.

Autologous conditioned plasma group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead

Study Sites (1)

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (8)

• Spakova T. Re: Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2014 Jan;93(1):95. doi: 10.1097/phm.0b013e318282ea04. No abstract available.

  PMID: 24501778 BACKGROUND

• Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.

  PMID: 21831567 BACKGROUND

• Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.

  PMID: 23104611 BACKGROUND

• Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.

  PMID: 23299850 BACKGROUND

• Li M, Zhang C, Ai Z, Yuan T, Feng Y, Jia W. [Therapeutic effectiveness of intra-knee-articular injection of platelet-rich plasma on knee articular cartilage degeneration]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Oct;25(10):1192-6. Chinese.

  PMID: 22069972 BACKGROUND

• Filardo G, Kon E, Di Martino A, Di Matteo B, Merli ML, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma vs hyaluronic acid to treat knee degenerative pathology: study design and preliminary results of a randomized controlled trial. BMC Musculoskelet Disord. 2012 Nov 23;13:229. doi: 10.1186/1471-2474-13-229.

  PMID: 23176112 BACKGROUND

• Vaquerizo V, Plasencia MA, Arribas I, Seijas R, Padilla S, Orive G, Anitua E. Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: a randomized controlled trial. Arthroscopy. 2013 Oct;29(10):1635-43. doi: 10.1016/j.arthro.2013.07.264.

  PMID: 24075613 BACKGROUND

• Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

  PMID: 26831629 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; orthovisc

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Director of Research
• Organization: Andrews Research & Education Foundation

jessica.truett@andrewsref.org

8509168570

Study Officials

• Adam Anz, MD

  Andrews Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the type of injection that they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 26, 2019
• Study Start: March 15, 2019
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)