Knee OsteoarthritisPhase 2/3NCT03889925
Effect of Different Injection Regimens of Autologous Conditioned Plasma for Knee Osteoarthritis
A Phase 2/3 study testing Hyaluronan and Autologous conditioned plasma in people with Knee Osteoarthritis, run by Andrews Research & Education Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hyaluronan and Autologous conditioned plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 17 Oct 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, 32561
About this study
Official title: Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis
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.
Read the detailed description
Patients between the ages of 30 and 80 who have documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence grades 1-4) will be screened for participation in this study. Patients must have a documented diagnosis of primary OA for at least six weeks. 80 patients will be recruited through the Andrews Institute physician practices. The study design will be a randomized control trial. Participants who meet the inclusion criteria will have the study explained in detail, and informed consent will be obtained as outlined above. Participants will complete patient-reported outcome questionnaires prior to their injection. The questionnaires will include the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS). Participants will also complete these questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection. A trained medical professional will draw blood from the patient's arm, and the blood will be spun in a centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated for injection into the patient's knee. The treating physician will then inject the ACP into the involved knee joint following standard aseptic technique per the physician's standard of care. This entire process will be completed in a single patient visit. Any unused portion of a sample in the physician's office will be disposed of through standard biohazard waste disposal systems as required by law. Group 1 [ACP]: Will receive three intra-articular injections of autologous conditioned plasma dosed once a week for three weeks. Group 2 [ACP-HA]: Will receive two intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for two weeks and a third injection on the third week of ACP.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hyaluronan, Autologous conditioned plasma
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronanDrug
Also called Hymovis, Monovisc, Orthovisc
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.
Autologous conditioned plasmaBiological
Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hyaluronan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months post injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start15 Mar 2019
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Anz, MD, Principal investigator, Andrews Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889925
- Sponsor's protocol ID
- 1379083
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2019
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24501778Kon 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.
PubMed 21831567Cerza 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.
PubMed 23104611Patel 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.
PubMed 23299850Li 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.
PubMed 22069972Filardo 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.
PubMed 23176112Vaquerizo 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.
PubMed 24075613Smith 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.
PubMed 26831629
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Injection Regimens of Autologous Conditioned Plasma for the Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03889925
- Acronym / sponsor ID
- 1379083
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients between the ages of 30 and 80 who have documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence grades 1-4) will be screened for participation in this study. Patients must have a documented diagnosis of primary OA for at least six weeks. 80 patients will be recruited through the Andrews Institute physician practices. The study design will be a randomized control trial. Participants who meet the inclusion criteria will have the study explained in detail, and informed consent will be obtained as outlined above. Participants will complete patient-reported outcome questionnaires prior to their injection. The questionnaires will include the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS). Participants will also complete these questionnaires at 1, 3, 6, 12, 18, and 24 months after the final injection. A trained medical professional will draw blood from the patient's arm, and the blood will be spun in a centrifuge for 5 minutes at 1500 RPM. The platelets will then be separated for injection into the patient's knee. The treating physician will then inject the ACP into the involved knee joint following standard aseptic technique per the physician's standard of care. This entire process will be completed in a single patient visit. Any unused portion of a sample in the physician's office will be disposed of through standard biohazard waste disposal systems as required by law. Group 1 [ACP]: Will receive three intra-articular injections of autologous conditioned plasma dosed once a week for three weeks. Group 2 [ACP-HA]: Will receive two intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for two weeks and a third injection on the third week of ACP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous conditioned plasma group | Experimental | Biological: Autologous conditioned plasmaParticipants in this group will receive a three-injection series of autologous conditioned plasma over the course of 3 consecutive weeks. |
| Autologous conditioned plasma with hyaluronic acid group | Experimental | Drug: HyaluronanParticipants 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyaluronanAlso: Hymovis, Monovisc, OrthoviscPatients 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. | Drug | Autologous conditioned plasma with hyaluronic acid group |
| Autologous conditioned plasmaPatients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks. | Biological | Autologous conditioned plasma group |
Primary outcome
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.
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.
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; A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24501778Spakova 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.
- Background: PubMed 21831567Kon 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.
- Background: PubMed 23104611Cerza 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.
- Background: PubMed 23299850Patel 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.
- Background: PubMed 22069972Li 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.
- Background: PubMed 23176112Filardo 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.
- Background: PubMed 24075613Vaquerizo 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.
- Background: PubMed 26831629Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Anz, MD principal investigator
Andrews Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyaluronan and Autologous conditioned plasma in people with Knee Osteoarthritis, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03889925, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.