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CompletedNCT03479749Updated Sep 24, 2021

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

An interventional study of RegenoGel-OSP, RegenoGel in Osteoarthritis, Knee, sponsored by ProCore Ltd.. Completed at 5 sites in Israel. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by ProCore Ltd. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 67 is close to the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

ProCore Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    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

  • Experimental
    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

  • 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

  • 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

Interventions

  • DeviceRegenoGel-OSP, RegenoGel

    RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.

06

What researchers measure

Primary outcomes

  1. Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)

    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.

    Time frame: Three months

  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.

    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).

    Time frame: Three months

Secondary outcomes

  1. Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)

    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.

    Time frame: Six months

  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

    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).

    Time frame: Six months

  3. Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

    Change in the subject´s activity in response to treatments based on the entire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

    Time frame: Three and Six months

  4. Change from baseline in quality of life in response to treatments using the SF-12 health survey.

    Change from baseline in quality of life in response to treatments using the SF-12 health survey.

    Time frame: Three and Six months

  5. Change in Subjective International Knee Documentation Committee score (IKDC).

    Change in Subjective International Knee Documentation Committee score (IKDC).

    Time frame: Three and Six months

  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.

    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.

    Time frame: Up to 12 months post first injection

07

Study locations

5 sites
  • Hadassah Medical Center
    Jerusalem, Israel
  • Shaare Zedek
    Jerusalem, Israel
  • Meir Medical Center
    Kfar Saba, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
  • Assaf Harofe Medical Center
    Zrifin, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03479749
Lead sponsor
ProCore Ltd.
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Feb 7, 2018
Primary completion
Mar 4, 2019
Completion
Mar 4, 2019
Last update
Sep 24, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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