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

NCT02188771 | Completed Phase 1

• 1 other identifier: PROC- 1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 treatment of OA. RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The viscoelastic properties resulting from the combination of these two natural macromolecules is further enhanced by joint surface associated factors to generate a viscoelastic gel with superior stability and mechanical integrity.

Conditions

Osteoarthritis

Keywords

Moderate to Severe OA; VAS score of ≥ 5; grade III-IV Kellgren Lawrence of OA; subjects who failed conservative treatment; subjects who candidates for total knee replacement (TKR); subject 45 and 75 years old; subject is experiencing pain in the intended study knee with a VAS score of ≥ 5; subject has a Body Mass Index (BMI) between 18.5 and 35

Outcome Measures

Primary Outcomes (1)

• Clinical safety and tolerability

  Incidence, relatedness, and severity of treatment-emergent SAEs, UAEs, AEs in the 2 treatment arms. Supportive safety measures: * Local safety outcomes (presence of erythema, edema, swelling, effusion, pain, sensitivity in the treated knee) * Global clinical assessment * Pain assessment * Percentage of subjects who discontinued the study due to AEs * Laboratory tests (haematology, blood chemistry, INR, aPTT), ECG and vital signs

  6 month following RegenoGel injection

Secondary Outcomes (1)

• Efficacy assessment

  6 month following RegenoGel injection

Study Arms (1)

RegenoGel SP 2ml

EXPERIMENTAL

RegenoGel-SP is a new viscosupplement intended for the intra-articular treatment of OA. Following signing the Informed Consent form (Visit 1), subjects who conform to the inclusion criteria will be evaluated for vital signs, blood hematology, chemistry, INR, aPTT and ECG, and will be subjected to a 30-40ml blood withdrawal that will be used for the production of autologous RegenoGel-SP. Subjects randomized to receive RegenoGel-SP will receive a single, intra-articular injection (Visit 2).

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

Interventions

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

Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA

RegenoGel SP 2ml

Eligibility Criteria

• Age: 45 Years - 75 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 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

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 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

Sponsors & Collaborators

• ProCore Ltd.: lead

Study Sites (1)

Assaf Harofe Medical Center

Zrifin, Israel

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gabrilet Agar, Dr

  Assaf Harofe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 27, 2017

Record last verified: 2014-07

Locations

IL (1)