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The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03479749
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
ProCore Ltd.

Study Description
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Brief Summary:
This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: RegenoGel-OSP, RegenoGel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Intra-articular Injection of RegenoGel-OSP and RegenoGel as a Treatment of Osteoarthritis (OA)
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: RegenoGel-OSP - RegenoGel-OSP
First injection- the patients will receive RegenoGel-OSP; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP also
 Device: RegenoGel-OSP, RegenoGel
RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
Placebo Comparator: RegenoGel - RegenoGel
First injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also
 Device: RegenoGel-OSP, RegenoGel
RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
Placebo Comparator: Placebo - RegenoGel-OSP
First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP
 Device: RegenoGel-OSP, RegenoGel
RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
Placebo Comparator: Placebo - RegenoGel
First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel
 Device: RegenoGel-OSP, RegenoGel
RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) [ Time Frame: Three months ]
    Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here.

  2. Efficacy assessment on change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. [ Time Frame: Three months ]
    Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (Pain both at rest and during exercise).


Secondary Outcome Measures :
  1. Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) [ Time Frame: Six months ]
    Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here.

  2. Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Six months ]
    Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (pain both at rest and during exercise).

  3. Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Three and Six months ]
    Change in the subject´s activity in response to treatments based on the entire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

  4. Change from baseline in quality of life in response to treatments using the SF-12 health survey. [ Time Frame: Three and Six months ]
    Change from baseline in quality of life in response to treatments using the SF-12 health survey.

  5. Change in Subjective International Knee Documentation Committee score (IKDC). [ Time Frame: Three and Six months ]
    Change in Subjective International Knee Documentation Committee score (IKDC).

  6. Clinical safety and tolerability assessments which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms. [ Time Frame: Up to 12 months post first injection ]
    Clinical safety and tolerability assessments up to 12 months post 1st injection which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has signed and dated the informed consent form
  2. Subject is a male or female between 55≤ and ≤ 80 years of age
  3. Subject is experiencing pain in the intended study knee with an average VAS score of ≥ 5 over the last week prior to screening.
  4. Subject with degenerative changes in the intended study knee that can be categorized as grade II-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee. This grade will be determined by the physician discretion and also by the Computerized, Automated X-ray-based Scoring and determination of Kellgren Lawrence software. Both methods should indicate a KL grade between II-IV in order for a subject to be eligible for the study.
  5. Subject has a Body Mass Index (BMI) between 18.5 and 35

Exclusion Criteria:

  1. Subjects with history of significant knee trauma to the intended study knee or with previous arthroscopic surgery of the intended study knee within the last 3 months preceding screening.
  2. Subject is experiencing pain in both knees with a VAS score of ≥ 5.
  3. Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
  4. Subject has less than 12-month life-expectancy.
  5. Subject is on chronic administration of pain medications (especially opioid pain relievers) and is unable to stop them from the day before each study visit through completion of the study visit.
  6. Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis or any other inflammatory condition associated with arthritis
  7. Subject has a wound in the area of the intended study knee
  8. Subject has fever signs or symptoms of systemic infection or infection of the intended study knee, on the day before or the day of administration of treatment or placebo.
  9. Subject has known sensitivity to any of the treatment components, egg, rubber or latex
  10. Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products
  11. Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease
  12. Subject has ever had cellulitis of the lower extremities, a peripheral vascular disease, or a personal history of clotting disorders.
  13. Subject has had cancer in the past 3 years or surgery involving the chest, abdomen, pelvis, or lower extremities in the past year
  14. Subject received any treatment with investigational device or product within 30 days prior to Visit l
  15. Subject has any recent (acute) or chronic medical, psychiatric, or social problem that might: 1) interfere with the Subject's performance or completion of the trial; 2) obfuscate the Subject's study data; or 3) render the Subject unable to understand the nature, scope, and possible consequences of the study
  16. Subject is receiving an antiplatelet and/or anticoagulation medicines (other than Aspirin)
  17. Subject ever abused drugs or alcohol (self-reported)
  18. Subject received a blood transfusion within 6 months prior to Screening.
  19. Subject donated blood or blood products within 3 months prior to Screening
  20. Subject has any elective surgery of any kind to the lower extremities or elective surgery requiring general anesthesia scheduled during the course of the trial
  21. Subject suffering from severe form of grade KL4 such as total cartilage loss with "bone on bone" as determined by the investigator or by the Computerized, Automated X-ray-based Scoring software.
  22. Subject suffering from severe OA and is not able to walk due to pain
  23. Pregnant or lactating woman
Contacts and Locations
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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): NCT03479749


Contacts
Contact: Avner Yayon, CEO +972-8-9303000 yayon@procore-bio.com

Locations
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Leonid (Arieh) Kandel, Dr.    +972-2-5844500    kandel@hadassah.org.il   
Principal Investigator: Leonid (Arieh) Kandel, Dr.         
Shaare Zedek Recruiting
Jerusalem, Israel
Contact: Aybek Sharipov, Dr.    +972-2-6666470    Shayk77@szmc.org.il   
Principal Investigator: Aybek Sharipov, Dr.         
Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Contact: Omer Slevin, Dr.    +972-9-7471140    Omer.Slevin@clalit.org.il   
Principal Investigator: Omer Slevin, Dr.         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Ori Elkayam, Prof.    +972-3-6973668    orie@tlvmc.gov.il   
Principal Investigator: Ori Elkayam, Prof.         
Assaf Harofe Medical Center Recruiting
Zrifin, Israel
Contact: Gabriel Agar, Dr    +972- 8-9779436    gagar@012.net.il   
Principal Investigator: Gabriel Agar, Dr         
Sponsors and Collaborators
ProCore Ltd.
More Information
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Responsible Party: ProCore Ltd.
ClinicalTrials.gov Identifier: NCT03479749     History of Changes
Other Study ID Numbers: PROC-2
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases