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Knee OsteoarthritisPhase 2/3NCT03850080

Autologous Conditioned Serum: Functional and Clinical Results

A Phase 2/3 study testing Autologous Conditioned Serum in people with Knee Osteoarthritis and Osteoarthritis, Knee, run by Ospedale San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA). Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Autologous Conditioned Serum
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
6 Oct 2017to 28 Sep 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • knee osteoarthritis >3 months in clinical and radiographic signs
  • VAS for pain >50mm

Who cannot join

  • Hepatitis B
  • Hepatitis C
  • HIV
  • pregnancy
  • drug abuse
  • other intra-articular injections <6 months
  • surgery on affected knee <12 months

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

About this study

Official title: Autologous Conditioned Serum: Functional and Clinical Results Using a Novel Disease Modifying Agent for the Management of Knee Osteoarthritis

The purpose of this study was to investigate the potential ability of autologous conditioned serum (ACS) to decrease the pain and improve the joint functionality in patients affected by knee osteoarthritis (OA).

Read the detailed description

Fifteen patients with clinical and radiological signs of OA of the hip or knee were recruited for this study. Each patient received 4 injections of ACS (Orthokine®) at the site of OA once per week for 4 weeks. Clinical and functional evaluation were performed using VAS scale for pain, WOMAC scale and KSS functional and clinical scores before the first injection, at one week, at two weeks, at three weeks, at one month and at six months. Statistical analysis was done with the Wilcoxon Signed-Rank Test.

Being tested
Autologous Conditioned Serum
Keywords
Knee, Osteoarthritis, Inflammation, Joint, Autologous Conditioned Serum
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Conditioned SerumDrug

    Also called ACS, Orthokine®

    Fifteen patients with clinical and radiological signs of OA of the knee were recruited for this study. 50mL of whole blood were taken using a special syringe containing CrSO4-coated grade glass beads in order to promote IL-1ra synthesis and aggregation.The incubation period lasted 7 hours after which, the blood-filled syringes were centrifuged and the serum supernatant was filtered and aliquoted into four 3mL portions. The aliquots were stored at -20oC until their use was necessary.

    Patients received 1 intra-articular injection for 4 consecutive weeks at the site of OA.

Study groups in NCT03850080
Study groupRoleWhat they receive
Autologous Conditioned SerumExperimentalPatients that were deemed admissible to the trial received 1 intra-articular injection of autologous conditioned serum (Orthokine®) for 4 consecutive weeks at the site of OA. These patients were then followed at 1 month and 6 months for clinical and functional evaluation using VAS for pain, WOMAC, and KSS.
Receives: Drug: Autologous Conditioned Serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

    24 questions each scaled out of 100mm. 5 questions regarding pain. 2 questions regarding rigidity. 17 questions regarding difficulty in various activities. Total score out of 240 expressed as a percentage. Minimum score 0. Max score 100. Greater score implies worsening symptomatology.

    Measured: 6 months

  2. Knee Society Score (KSS)

    Clinical Score. Pain is measured out of 50 (no pain = 50, severe pain = 0). Range of motion (1 point for every 5 degress of flexion. Max points = 25). Stability; anteroposterior (<5 degrees 10, 5-10 degrees 5, >10 degrees 0); mediolateral (<5 degrees = 10, 5-10 degrees = 5, >10 degrees = 0); Flexion contracture (5-10 degrees = -2, 10-15 degrees = -5, 16-20 degrees = -10, >20 degrees = -15); Extension lag (<10 degrees = -5, 10-20 degrees = -10, 20 degrees = -15); Alignment (0-4 degrees = 0, 5-15 degrees = 3 points for each degree).

    Functional Score. Consists of walking score based on how many blocks (100m) patient can walk without stopping (unlimited = 100, >10 blocks = 40, 5-10 blocks = 30, <5 blocks = 20, housebound = 10, unable = 0); Stairs (normal = 50, normal up down with support = 40, up and down with support = 30, up with support down unable = 15, unable = 0); Functional deductions (cane = -5, two canes = -10, crutches or walker = -20)

    Measured: 6 months

  3. Visual Analog Score for Pain

    Subjective evaluation of pain reported by each patient on average since the last visit. Minimum = 0. Maximum = 10

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start6 Oct 2017
  3. Primary completion28 Sep 2018
  4. Study completion28 Sep 2018

Resources

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
Not applicable
Intervention model
Single group
Model description
Single cohort prospective interventional study
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850080
Sponsor's protocol ID
1ACS
Status last verified
Feb 2019
First submitted
20 Feb 2019
Last updated
22 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shewale AR, Barnes CL, Fischbach LA, Ounpraseuth ST, Painter JT, Martin BC. Comparative Effectiveness of Intra-Articular Hyaluronic Acid and Corticosteroid Injections on the Time to Surgical Knee Procedures. J Arthroplasty. 2017 Dec;32(12):3591-3597.e24. doi: 10.1016/j.arth.2017.07.007. Epub 2017 Jul 14.

    PubMed 28781020

  • Klocke R, Levasseur K, Kitas GD, Smith JP, Hirsch G. Cartilage turnover and intra-articular corticosteroid injections in knee osteoarthritis. Rheumatol Int. 2018 Mar;38(3):455-459. doi: 10.1007/s00296-018-3988-2. Epub 2018 Feb 2.

    PubMed 29396701

  • Bhandari M, Bannuru RR, Babins EM, Martel-Pelletier J, Khan M, Raynauld JP, Frankovich R, Mcleod D, Devji T, Phillips M, Schemitsch EH, Pelletier JP. Intra-articular hyaluronic acid in the treatment of knee osteoarthritis: a Canadian evidence-based perspective. Ther Adv Musculoskelet Dis. 2017 Sep;9(9):231-246. doi: 10.1177/1759720X17729641. Epub 2017 Sep 12.

    PubMed 28932293

  • Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001 Jun;44(6):1237-47. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-F. No abstract available.

    PubMed 11407681

  • Nuki G. Osteoarthritis: a problem of joint failure. Z Rheumatol. 1999 Jun;58(3):142-7. doi: 10.1007/s003930050164.

    PubMed 10441841

  • Kapoor M, Martel-Pelletier J, Lajeunesse D, Pelletier JP, Fahmi H. Role of proinflammatory cytokines in the pathophysiology of osteoarthritis. Nat Rev Rheumatol. 2011 Jan;7(1):33-42. doi: 10.1038/nrrheum.2010.196. Epub 2010 Nov 30.

    PubMed 21119608

  • Martel-Pelletier J, Alaaeddine N, Pelletier JP. Cytokines and their role in the pathophysiology of osteoarthritis. Front Biosci. 1999 Oct 15;4:D694-703. doi: 10.2741/martel.

    PubMed 10525480

  • Nixon AJ, Grol MW, Lang HM, Ruan MZC, Stone A, Begum L, Chen Y, Dawson B, Gannon F, Plutizki S, Lee BHL, Guse K. Disease-Modifying Osteoarthritis Treatment With Interleukin-1 Receptor Antagonist Gene Therapy in Small and Large Animal Models. Arthritis Rheumatol. 2018 Nov;70(11):1757-1768. doi: 10.1002/art.40668. Epub 2018 Sep 10.

    PubMed 30044894

  • Calich AL, Domiciano DS, Fuller R. Osteoarthritis: can anti-cytokine therapy play a role in treatment? Clin Rheumatol. 2010 May;29(5):451-5. doi: 10.1007/s10067-009-1352-3. Epub 2010 Jan 27.

    PubMed 20108016

  • Alvarez-Camino JC, Vazquez-Delgado E, Gay-Escoda C. Use of autologous conditioned serum (Orthokine) for the treatment of the degenerative osteoarthritis of the temporomandibular joint. Review of the literature. Med Oral Patol Oral Cir Bucal. 2013 May 1;18(3):e433-8. doi: 10.4317/medoral.18373.

    PubMed 23524415

  • Buckland-Wright C. Subchondral bone changes in hand and knee osteoarthritis detected by radiography. Osteoarthritis Cartilage. 2004;12 Suppl A:S10-9. doi: 10.1016/j.joca.2003.09.007.

    PubMed 14698636

  • Baltzer AW, Moser C, Jansen SA, Krauspe R. Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis. Osteoarthritis Cartilage. 2009 Feb;17(2):152-60. doi: 10.1016/j.joca.2008.06.014. Epub 2008 Jul 31.

    PubMed 18674932

  • Fox BA, Stephens MM. Treatment of knee osteoarthritis with Orthokine-derived autologous conditioned serum. Expert Rev Clin Immunol. 2010 May;6(3):335-45. doi: 10.1586/eci.10.17.

    PubMed 20441419

  • Wehling P, Moser C, Frisbie D, McIlwraith CW, Kawcak CE, Krauspe R, Reinecke JA. Autologous conditioned serum in the treatment of orthopedic diseases: the orthokine therapy. BioDrugs. 2007;21(5):323-32. doi: 10.2165/00063030-200721050-00004.

    PubMed 17896838

  • Auw Yang KG, Raijmakers NJ, van Arkel ER, Caron JJ, Rijk PC, Willems WJ, Zijl JA, Verbout AJ, Dhert WJ, Saris DB. Autologous interleukin-1 receptor antagonist improves function and symptoms in osteoarthritis when compared to placebo in a prospective randomized controlled trial. Osteoarthritis Cartilage. 2008 Apr;16(4):498-505. doi: 10.1016/j.joca.2007.07.008. Epub 2007 Sep 6.

    PubMed 17825587

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Autologous Conditioned Serum in people with Knee Osteoarthritis and Osteoarthritis, Knee, run by Ospedale San Raffaele at 1 site in Italy.

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 2 inclusion and 7 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 22 Feb 2019. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 & McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 6 months). 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 NCT03850080, which also lists 15 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 22 Feb 2019.

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