Osteoarthritis, KneeNCT03479749
The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis
A study testing RegenoGel-OSP, RegenoGel in people with Osteoarthritis, Knee, run by ProCore Ltd. at 5 sites in Israel.
Trial summary
This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- RegenoGel-OSP, RegenoGel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 5 sitesIsrael
- Study dates
- 7 Feb 2018to 4 Mar 2019
- Phase
- Interventional
- 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 55 to 80 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 a male or female between 55≤ and ≤ 80 years of age
- Subject is experiencing pain in the intended study knee with an average VAS score of ≥ 5 over the last week prior to screening.
- Subject with degenerative changes in the intended study knee that can be categorized as grade II-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee. This grade will be determined by the physician discretion and also by the Computerized, Automated X-ray-based Scoring and determination of Kellgren Lawrence software. Both methods should indicate a KL grade between II-IV in order for a subject to be eligible for the study.
- Subject has a Body Mass Index (BMI) between 18.5 and 35
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 is experiencing pain in both knees with a VAS score of ≥ 5.
- Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
- Subject has less than 12-month life-expectancy.
- Subject is on chronic administration of pain medications (especially opioid pain relievers) and is unable to stop them 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
Show all 23Show fewer
- Subject has a wound in the area of the intended study knee
- Subject has fever signs or symptoms of systemic infection or infection of the intended study knee, on the day before or the day of administration of treatment or placebo.
- 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 known Human Immunodeficiency Virus / Acquired 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 peripheral vascular disease, or a personal history of clotting disorders.
- Subject has had cancer in the past 3 years or surgery involving the chest, abdomen, pelvis, or lower extremities in the past year
- Subject received any treatment with investigational device or product within 30 days prior to 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 antiplatelet and/or anticoagulation medicines (other than Aspirin)
- Subject ever abused drugs or alcohol (self-reported)
- Subject received a blood transfusion within 6 months prior to Screening.
- Subject donated blood or blood products within 3 months prior to Screening
- 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
- Subject suffering from severe form of grade KL4 such as total cartilage loss with "bone on bone" as determined by the investigator or by the Computerized, Automated X-ray-based Scoring software.
- Subject suffering from severe OA and is not able to walk due to pain
- Pregnant or lactating woman
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Hadassah Medical Center
Jerusalem
Shaare Zedek
Jerusalem
Meir Medical Center
Kfar Saba
Tel Aviv Sourasky Medical Center
Tel Aviv
Assaf Harofe Medical Center
Zrifin
About this study
Official title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Intra-articular Injection of RegenoGel-OSP and RegenoGel as a Treatment of Osteoarthritis (OA)
This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- RegenoGel-OSP, RegenoGel
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegenoGel-OSP, RegenoGelDevice
RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
| Study group | Role | What they receive |
|---|---|---|
| RegenoGel-OSP - RegenoGel-OSP | Experimental | First injection- the patients will receive RegenoGel-OSP; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP also Receives: Device: RegenoGel-OSP, RegenoGel |
| RegenoGel - RegenoGel | Experimental | First injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also Receives: Device: RegenoGel-OSP, RegenoGel |
| Placebo - RegenoGel-OSP | Placebo comparator | First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP Receives: Device: RegenoGel-OSP, RegenoGel |
| Placebo - RegenoGel | Placebo comparator | First injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel Receives: Device: RegenoGel-OSP, RegenoGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)
Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here.
Measured: Three months
Efficacy assessment on change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (Pain both at rest and during exercise).
Measured: Three months
Secondary outcomes (6)
Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)
Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here.
Measured: Six months
Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (pain both at rest and during exercise).
Measured: Six months
Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Change in the subject´s activity in response to treatments based on the entire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Measured: Three and Six months
Change from baseline in quality of life in response to treatments using the SF-12 health survey.
Change from baseline in quality of life in response to treatments using the SF-12 health survey.
Measured: Three and Six months
Change in Subjective International Knee Documentation Committee score (IKDC).
Change in Subjective International Knee Documentation Committee score (IKDC).
Measured: Three and Six months
Clinical safety and tolerability assessments which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms.
Clinical safety and tolerability assessments up to 12 months post 1st injection which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms.
Measured: Up to 12 months post first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start7 Feb 2018
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProCore Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479749
- Sponsor's protocol ID
- PROC-2
- Status last verified
- Sep 2021
- First submitted
- 12 Mar 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Intra-articular Injection of RegenoGel-OSP and RegenoGel as a Treatment of Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT03479749
- Acronym / sponsor ID
- PROC-2
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- ProCore Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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 study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RegenoGel-OSP - RegenoGel-OSP | Experimental | Device: RegenoGel-OSP, RegenoGelFirst injection- the patients will receive RegenoGel-OSP; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP also |
| RegenoGel - RegenoGel | Experimental | Device: RegenoGel-OSP, RegenoGelFirst injection- the patients will receive RegenoGel; Second injection (after 3 months interval)- the patients will receive RegenoGel also |
| Placebo - RegenoGel-OSP | Placebo comparator | Device: RegenoGel-OSP, RegenoGelFirst injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel-OSP |
| Placebo - RegenoGel | Placebo comparator | Device: RegenoGel-OSP, RegenoGelFirst injection- the patients will receive Placebo; Second injection (after 3 months interval)- the patients will receive RegenoGel |
Who may qualify
- Ages
- 55 to 80 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 a male or female between 55≤ and ≤ 80 years of age
- Subject is experiencing pain in the intended study knee with an average VAS score of ≥ 5 over the last week prior to screening.
- Subject with degenerative changes in the intended study knee that can be categorized as grade II-IV Kellgren Lawrence based upon standing posterior-anterior and lateral radiographs of the knee. This grade will be determined by the physician discretion and also by the Computerized, Automated X-ray-based Scoring and determination of Kellgren Lawrence software. Both methods should indicate a KL grade between II-IV in order for a subject to be eligible for the study.
- Subject has a Body Mass Index (BMI) between 18.5 and 35
Key exclusion criteria (23 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 is experiencing pain in both knees with a VAS score of ≥ 5.
- Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
- Subject has less than 12-month life-expectancy.
- Subject is on chronic administration of pain medications (especially opioid pain relievers) and is unable to stop them from the day before each study visit through completion of the study visit.
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 |
|---|---|---|
| RegenoGel-OSP, RegenoGelRegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA. | Device | Placebo - RegenoGel, Placebo - RegenoGel-OSP, RegenoGel - RegenoGel, RegenoGel-OSP - RegenoGel-OSP |
Primary outcome
Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)
Time frame: Three months
Change in pain in the effected knee joint in response to treatment using the Visual Analog Score (VAS). VAS score is measured according to the patient's pain rating scale from 1 to 10. The scale of pain increases with increasing pain. For example, score 1 indicates absence of pain (minimum score) and score 10 indicates unbearable pain (maximum score). Each VAS score amounts to only one number of outcome from 1 to 10. VAS will be determined in resting position and in active position. No subscales are combined here.
Efficacy assessment on change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Time frame: Three months
Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (Pain both at rest and during exercise).
6 secondary outcomes
Change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS)
Time frame: Six months
Change in pain in the affected knee joint in response to treatment based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Six months
Change in the subject´s activity in response to treatments based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Three and Six months
Change from baseline in quality of life in response to treatments using the SF-12 health survey.
Time frame: Three and Six months
Change in Subjective International Knee Documentation Committee score (IKDC).
Time frame: Three and Six months
Clinical safety and tolerability assessments which will include: incidence, relatedness and severity of treatment-emergent SAE's, UAE's and AE's in the treatment arms.
Time frame: Up to 12 months post first 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 24 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RegenoGel-OSP, RegenoGel in people with Osteoarthritis, Knee, run by ProCore Ltd. at 5 sites 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 23 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Efficacy assessment on change in pain in the affected knee joint in response to treatment using the Visual Analog Score (VAS) (time frame: Three months). The study lists 2 primary outcomes in all. 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 24 Sep 2021.