Autologous Conditioned Serum: Functional and Clinical Results

NCT03850080 | Completed Phase 2

• 1 other identifier: 1ACS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Knee Osteoarthritis; Osteoarthritis, Knee; Cartilage Degeneration

Keywords

Knee; Osteoarthritis; Inflammation; Joint; Autologous Conditioned Serum

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• 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)

  6 months

• Visual Analog Score for Pain

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

  6 months

Study Arms (1)

Autologous Conditioned Serum

EXPERIMENTAL

Patients 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.

Drug: Autologous Conditioned Serum

Interventions

Autologous Conditioned Serum DRUG

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.

Also known as: ACS, Orthokine®

Autologous Conditioned Serum

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (15)

• 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.

  PMID: 28781020 BACKGROUND

• 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.

  PMID: 29396701 BACKGROUND

• 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.

  PMID: 28932293 BACKGROUND

• 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.

  PMID: 11407681 BACKGROUND

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

  PMID: 10441841 BACKGROUND

• 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.

  PMID: 21119608 BACKGROUND

• 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.

  PMID: 10525480 BACKGROUND

• 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.

  PMID: 30044894 BACKGROUND

• 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.

  PMID: 20108016 BACKGROUND

• 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.

  PMID: 23524415 BACKGROUND

• 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.

  PMID: 14698636 BACKGROUND

• 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.

  PMID: 18674932 RESULT

• 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.

  PMID: 20441419 RESULT

• 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.

  PMID: 17896838 RESULT

• 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.

  PMID: 17825587 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Inflammation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Vitali, MD

  Ospedale San Raffaele

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Single cohort prospective interventional study

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: October 6, 2017
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)