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

NCT03479749 | Completed

• 1 other identifier: PROC-2
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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.

  Three months

• 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).

  Three months

Secondary Outcomes (6)

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

  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

  Six months

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

  Three and Six months

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

  Three and Six months

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

  Three and Six months

Study Arms (4)

RegenoGel-OSP - RegenoGel-OSP

EXPERIMENTAL

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 - RegenoGel

EXPERIMENTAL

First injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also

Device: RegenoGel-OSP, RegenoGel

Placebo - RegenoGel-OSP

PLACEBO COMPARATOR

First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP

Device: RegenoGel-OSP, RegenoGel

Placebo - RegenoGel

PLACEBO COMPARATOR

First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel

Device: RegenoGel-OSP, RegenoGel

Interventions

RegenoGel-OSP, RegenoGel DEVICE

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

Placebo - RegenoGel; Placebo - RegenoGel-OSP; RegenoGel - RegenoGel; RegenoGel-OSP - RegenoGel-OSP

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed and dated the informed consent form
• Subject is a male or female between 55≤ and ≤ 80 years of age
• Subject is experiencing pain in the intended study knee with an average VAS score of ≥ 5 over the last week prior to screening.
• 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.
• Subject has a Body Mass Index (BMI) between 18.5 and 35

You may not qualify if:

• 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.
• Subject is experiencing pain in both knees with a VAS score of ≥ 5.
• Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
• Subject has less than 12-month life-expectancy.
• 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.
• Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis or any other inflammatory condition associated with arthritis
• Subject has a wound in the area of the intended study knee
• 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.
• Subject has known sensitivity to any of the treatment components, egg, rubber or latex
• Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products
• Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease
• Subject has ever had cellulitis of the lower extremities, a peripheral vascular disease, or a personal history of clotting disorders.
• Subject has had cancer in the past 3 years or surgery involving the chest, abdomen, pelvis, or lower extremities in the past year
• Subject received any treatment with investigational device or product within 30 days prior to Visit l
• 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

Sponsors & Collaborators

• ProCore Ltd.: lead

Study Sites (5)

Hadassah Medical Center

Jerusalem, Israel

Location

Shaare Zedek

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Assaf Harofe Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 27, 2018
• Study Start: February 7, 2018
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

IL (5)