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
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|ClinicalTrials.gov Identifier: NCT02188771|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : April 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: RegenoGel SP 2ml
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)
Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA
- Clinical safety and tolerability [ Time Frame: 6 month following RegenoGel injection ]
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
- Efficacy assessment [ Time Frame: 6 month following RegenoGel injection ]
- Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS).
- Change in the subject´s activity in response to treatments based on the WOMAC evaluation form.
- Change in quality of life at baseline in response to treatments using the SF-36v2 health survey.
- Change in joint space width using standard X-ray in response to treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188771
|Assaf Harofe Medical Center|
|Principal Investigator:||Gabrilet Agar, Dr||Assaf Harofe Medical Center|