A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02188771
• Date of registration: 10/07/2014
• Prospective Registration: No
• Primary sponsor: ProCore Ltd.
• Public title: A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis
• Date of first enrolment: February 2014
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02188771
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Israel

Contacts

• Name: Gabrilet Agar, Dr
• Affiliation: Assaf Harofe Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has signed and dated the informed consent form

- Subject is experiencing pain in the intended study knee with a VAS score of = 5

- Subject with degenerative changes in the intended study knee that can be categorized
as grade III-IV Kellgren Lawrence based upon standing posterior-anterior and lateral
radiographs of the knee and is a candidate for TKR

- Subject has a Body Mass Index (BMI) between 18.5 and 35

- Subject has failed conservative treatments to the intended study knee, including such
measures as weight reduction, physical therapy, hydrotherapy, analgesics,
non-steroidal anti-inflammatory drugs (NSAIDs) and/or intra-articular injections

Exclusion Criteria:

- 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 had any intra-articular injections to the intended study knee within 6 months
prior to Screening

- Subject is unable to stop chronic administration of pain medications (including
paracetamol), 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 superficial wound in the area of the intended study knee

- 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 a clinically significant abnormal finding (e.g., laboratory result or ECG)
on screening

- Subject has clinically significant abnormal INR or aPTT coagulation result.

- Subject has a hemoglobin concentration below 10.5

- Subject is positive for Human Immunodeficiency Virus / Aquired 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 superficial or deep vein
thrombosis, or a family history of a clotting disorders

- Subject has had cancer in the past 5 years or surgery involving the chest, abdomen,
pelvis, or lower extremities in the past year

- Subject receives any investigational device or product within 30 days of 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

- Subject is receiving an oral or injected anticoagulant

- Subject ever abused drugs or alcohol (self-reported)

- Subject received a blood transfusion within 6 months prior to Visit 1.

- Subject donated blood or blood products within 3 months prior to Visit 1.

- 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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Device: intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)

Primary Outcome(s)

Clinical safety and tolerability [Time Frame: 6 month following RegenoGel injection]

Secondary Outcome(s)

Efficacy assessment [Time Frame: 6 month following RegenoGel injection]

Secondary ID(s)

PROC- 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors