OsteoarthritisPhase 1/2NCT02188771
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
A Phase 1/2 study testing intra-articular administration of RegenoGel-SP or hyaluronic acid (HA) in people with Osteoarthritis, run by ProCore Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 randomization list that will be prepared prior to the start of the study. Randomization will be done at Enrollment (Visit 2). Neither surgeon nor subject will be blinded to treatment. Subjects will be monitored for 6 months following treatment. Following signing the Informed Consent form (Visit 1), subjects who conform to the inclusion criteria will answer questionnaires for grading of their symptoms, pain level and overall functional performance. Subjects 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), while subjects randomized to receive HA treatment (Euflexxa®) will be injected with 3 intra-articular weekly injections of (Visits 2-4). Subjects treated with RegenoGel-SP will attend visits 3 and 4 but will not receive treatment. All subjects will return for Observation visits after 6 weeks, 3 months and 6 months following treatment (Visits 5-7). During treatment and observation visits, subjects will be monitored for safety parameters (local and systemic AEs, blood work analysis ) and response to treatment using the above questionnaires.
- Conditions
- Osteoarthritis
- Being tested
- intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)
- 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
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)Device
Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: intra-articular administration of RegenoGel-SP or hyaluronic acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month following RegenoGel injection
Secondary outcomes (1)
Efficacy assessment
- 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
Measured: 6 month following RegenoGel injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProCore Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabrilet Agar, Dr, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188771
- Sponsor's protocol ID
- PROC- 1
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02188771
- Acronym / sponsor ID
- PROC- 1
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ProCore Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 randomization list that will be prepared prior to the start of the study. Randomization will be done at Enrollment (Visit 2). Neither surgeon nor subject will be blinded to treatment. Subjects will be monitored for 6 months following treatment. Following signing the Informed Consent form (Visit 1), subjects who conform to the inclusion criteria will answer questionnaires for grading of their symptoms, pain level and overall functional performance. Subjects 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), while subjects randomized to receive HA treatment (Euflexxa®) will be injected with 3 intra-articular weekly injections of (Visits 2-4). Subjects treated with RegenoGel-SP will attend visits 3 and 4 but will not receive treatment. All subjects will return for Observation visits after 6 weeks, 3 months and 6 months following treatment (Visits 5-7). During treatment and observation visits, subjects will be monitored for safety parameters (local and systemic AEs, blood work analysis ) and response to treatment using the above questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RegenoGel SP 2ml | Experimental | Device: intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)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). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA | Device | RegenoGel SP 2ml |
Primary outcome
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
1 secondary outcome
Efficacy assessment
Time frame: 6 month following RegenoGel injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrilet Agar, Dr principal investigator
Assaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intra-articular administration of RegenoGel-SP or hyaluronic acid (HA) in people with Osteoarthritis, run by ProCore Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical safety and tolerability (time frame: 6 month following RegenoGel injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.