IA Injection of Rejoint Gel and PRP in Patients With Unilateral Knee OA

NCT04519047 | Unknown Phase 1 DMC

• 1 other identifier: 201812157DSA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PRP; Knee Osteoarthritis

Keywords

PRP; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse events (AEs) and serious AEs

  Adverse events (AEs) and serious AEs

  Baseline to Visit 7 (15th week)

Secondary Outcomes (2)

• Western Ontario and McMaster Universities Index for osteoarthritis

  Baseline to Visit 7 (15th week)

• Kellgren-Lawrence grading scale

  Baseline to Visit 7 (15th week)

Study Arms (2)

Rejoint

EXPERIMENTAL

Rejoint+PRP

Biological: PRP

Control

ACTIVE COMPARATOR

Saline+PRP

Biological: PRP

Interventions

PRP BIOLOGICAL

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).

Control; Rejoint

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• The Industrial Technology Research Institute: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chueh-Hung Wu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chueh-Hung Wu, MD, PhD

CONTACT

+886223123456; nojred@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: August 13, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

TW (1)