Status:
UNKNOWN
IA Injection of Rejoint Gel and PRP in Patients With Unilateral Knee OA
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
The Industrial Technology Research Institute
Conditions:
PRP
Knee Osteoarthritis
Eligibility:
All Genders
45-80 years
Phase:
PHASE1
Brief 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.
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 administ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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;
- 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
- Exclusion criteria
- 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);
- 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
Exclusion
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04519047
Start Date
August 13 2020
End Date
December 31 2021
Last Update
August 24 2020
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100