Status:
COMPLETED
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
Lead Sponsor:
ProCore Ltd.
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial designed to assess the safety and tolerability of single intra-articular injection of RegenoGel-SP for the tre...
Detailed Description
Eighteen subjects will be randomized and sequentially assigned to RegenoGel-SP or to hyaluronic acid (HA) treatments on a 2:1 basis, respectively. Treatment groups will be assigned as per a randomizat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02188771
Start Date
February 1 2014
End Date
October 1 2015
Last Update
April 27 2017
Active Locations (1)
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1
Assaf Harofe Medical Center
Zrifin, Israel