PRPPhase 1NCT04519047
IA Injection of Rejoint Gel and PRP in Patients With Unilateral Knee OA
A Phase 1 study testing PRP in people with PRP and Knee Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To assess the safety and tolerability of intra-articular Injection doses of Rejoint Gel after platelet-rich plasma administration in unilateral knee OA subjects. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- PRP, Knee Osteoarthritis
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Aug 2020to 31 Dec 2021
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent before any study-specific procedure is performed;
- Ages of 45~80 years old on the day of consent;
- The patient is able to understand the nature of the study;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- Patient was diagnosed as OA of single knee joint by American College of Rheumatology (ACR) criteria; [i.e, knee pain, and any one of the following: age> 45 years, crepitus, or morning stiffness<30 minutes in duration, or confirmed through radiographic X ray];
- Knee WOMAC Pain Score (sum of five components) between 20 and 40 score, after 15 meters of walking pain;
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- Contralateral knee WOMAC Pain Score <15 score;
- Never receiving intra-articular hyaluronic acid (HA) injections of the knee, or last received intra-articular HA more than 6 months;
- Patient meets below conditions by blood test, kidney and liver function test :
- White blood cell (WBC) count > 3,000/μL Absolute neutrophil count (ANC) ≥ 1,500/μL Hemoglobin (Hb) ≥ 9.0 g/dL Thrombocyte count > 50,000/μL Blood urea nitrogen (BUN) and serum Creatinine ≤ 3X Upper Limit of Normal (ULN) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN
Who cannot join
- Known sensitivity to mPEG-PLGA hydrogel (Rejoint Gel);
- Infection in the joint or surrounding skin;
- Known Intra-articular neoplasm;
- Inflammatory joint disease, OA in the hips, osteonecrosis, moderate to marked effusion from index knee;
- Documented current positive synovial fluid culture;
- Large knee circumference (>45 cm);
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- History of herpes zoster in the past 3 months;
- Last receiving the treatment of immunosuppressants, anti-coagulants, Non-steroidal anti-inflammatory Drugs (NSAIDs), antidepressants 14 days prior to study randomization;
- Planned knee surgery in the next 6 months or received knee surgery in the past 6 months;
- Subject is receiving or is less than 28 days since ending other investigational device or drug;
- Known full-thickness cartilage loss in index knee;
- Documented fibromyalgia, or hemiparesis;
- Evidence of signs or symptoms of a viral, bacterial, or fungal infection occur 14 days prior to the study treatment starts, per the assessment of the investigator;
- Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results, such as terminal diseases, malignant tumors, heart failure (NYHA II-IV), coronary arterial disease, uncontrolled hypertension, uncontrolled diabetes, peripheral arterial disease or dementia, might prevent the subject from completing the study or interfere with the interpretation of the study results;
- Pre-menopausal females of childbearing potential not willing to use acceptable method(s) of birth control during treatment;
- Female subject who is lactating or pregnant
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chueh-Hung Wu, MD, PhD, 886223123456 ext. 66473, nojred@gmail.com
About this study
Official title: A Randomized, Double-blind, Feasibility Study to Evaluate the Safety and Potential for Effectiveness of Intra-articular Injection of Rejoint Gel After Platelet-rich Plasma Administration in Patients With Unilateral Knee Osteoarthritis
To assess the safety and tolerability of intra-articular Injection doses of Rejoint Gel after platelet-rich plasma administration in unilateral knee OA subjects.
Read the detailed description
This single-center, randomized, double-blind, feasibility study to evaluate the safety and potential for effectiveness of an intraarticular Injection of Rejoint Gel after platelet-rich plasma administration in patient with single knee OA, parallel-design study will enroll approximately eligible 30 subjects with single knee OA.
The subjects will be randomized (1:1) to receive 1 of 2 treatments below:
- Treatment Group: Rejoint Gel, intra-articular injection, with platelet-rich plasma (PRP) in 2:1 volume ratio or
- Control Group: Normal saline, intra-articular injection with PRP in 2:1 volume ratio Beginning on treatment period, subjects will receive a single treatment cycle of either 150 mg/ml Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4). Subjects will be followed to Visit 5, 6 and 7 for safety and potential for effectiveness assessments.
- Conditions
- PRP, Knee Osteoarthritis
- Being tested
- PRP
- Keywords
- PRP, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Beginning on treatment period, subjects will receive either Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4).
| Study group | Role | What they receive |
|---|---|---|
| Rejoint | Experimental | Rejoint+PRP Receives: Biological: PRP |
| Control | Active comparator | Saline+PRP Receives: Biological: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse events (AEs) and serious AEs
Adverse events (AEs) and serious AEs
Measured: Baseline to Visit 7 (15th week)
Secondary outcomes (2)
Western Ontario and McMaster Universities Index for osteoarthritis
Change in Western Ontario and McMaster Universities (WOMAC) Index for osteoarthritis: five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline to Visit 7 (15th week)
Kellgren-Lawrence grading scale
Change in the Kellgren-Lawrence (KL) Grading Scale: 0-IV (0: normal, IV: the worst)
Measured: Baseline to Visit 7 (15th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start13 Aug 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRPStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Industrial Technology Research Institute
- Responsible party
- Sponsor
- Investigators
- Chueh-Hung Wu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519047
- Sponsor's protocol ID
- 201812157DSA
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Feasibility Study to Evaluate the Safety and Potential for Effectiveness of Intra-articular Injection of Rejoint Gel After Platelet-rich Plasma Administration in Patients With Unilateral Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04519047
- Acronym / sponsor ID
- 201812157DSA
- Conditions
- PRP, Knee Osteoarthritis
- Keywords
- PRP, Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- The Industrial Technology Research Institute
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Aug 2020 (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.
To assess the safety and tolerability of intra-articular Injection doses of Rejoint Gel after platelet-rich plasma administration in unilateral knee OA subjects.
Detailed description
This single-center, randomized, double-blind, feasibility study to evaluate the safety and potential for effectiveness of an intraarticular Injection of Rejoint Gel after platelet-rich plasma administration in patient with single knee OA, parallel-design study will enroll approximately eligible 30 subjects with single knee OA.
The subjects will be randomized (1:1) to receive 1 of 2 treatments below:
- Treatment Group: Rejoint Gel, intra-articular injection, with platelet-rich plasma (PRP) in 2:1 volume ratio or
- Control Group: Normal saline, intra-articular injection with PRP in 2:1 volume ratio Beginning on treatment period, subjects will receive a single treatment cycle of either 150 mg/ml Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4). Subjects will be followed to Visit 5, 6 and 7 for safety and potential for effectiveness assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rejoint | Experimental | Biological: PRPRejoint+PRP |
| Control | Active comparator | Biological: PRPSaline+PRP |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent before any study-specific procedure is performed;
- Ages of 45~80 years old on the day of consent;
- The patient is able to understand the nature of the study;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- Patient was diagnosed as OA of single knee joint by American College of Rheumatology (ACR) criteria; [i.e, knee pain, and any one of the following: age> 45 years, crepitus, or morning stiffness<30 minutes in duration, or confirmed through radiographic X ray];
Key exclusion criteria (16 listed)
- Known sensitivity to mPEG-PLGA hydrogel (Rejoint Gel);
- Infection in the joint or surrounding skin;
- Known Intra-articular neoplasm;
- Inflammatory joint disease, OA in the hips, osteonecrosis, moderate to marked effusion from index knee;
- Documented current positive synovial fluid culture;
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 |
|---|---|---|
| PRPBeginning on treatment period, subjects will receive either Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4). | Biological | Control, Rejoint |
Primary outcome
Number of Participants with Adverse events (AEs) and serious AEs
Time frame: Baseline to Visit 7 (15th week)
Adverse events (AEs) and serious AEs
2 secondary outcomes
Western Ontario and McMaster Universities Index for osteoarthritis
Time frame: Baseline to Visit 7 (15th week)
Kellgren-Lawrence grading scale
Time frame: Baseline to Visit 7 (15th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Chueh-Hung Wu, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRP in people with PRP and Knee Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 24 Aug 2020. 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 Taiwan. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Hung Wu, MD, PhD (+886223123456 ext. 66473, nojred@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse events (AEs) and serious AEs (time frame: Baseline to Visit 7 (15th week)). 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 Aug 2020.