Orthopedic/Rheumatology

BioSolutions Open Protocol Summaries

INDICATION

AGE CRITERIA

DESCRIPTION

Rotator Cuff

40-75, inclusive

RC-002: A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection into Chronic Partial-Thickness Rotator Cuff Tears

OA Knee

> 40 yrs

A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients with Osteoarthritis of the Knee

OA Knee

40-80, inclusive

Samumed, LLC/ “A study to support the radiographic eligibility screening process of samumed studies in symptomatic knee osteoarthritis subjects”

Rheumatoid Arthritis

18 years or greater

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis

OA Knee

40-80, inclusive

A Phase 3, 28-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

OA Knee

Pts who participated in IA UBX0101 study

Long-term follow-up study of patients with moderate to severe, painful osteoarthritis of the knee who participated in a randomized, placebo-controlled study of UBX0101

BioSolutions Start-Up (Upcoming) Protocol Summaries

INDICATION

AGE CRITERIA

DESCRIPTION

OA Knee

≥ 40 yrs. old

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy and Effectiveness of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

Cartilage repair

18-60

A prospective, randomized, active treatment-controlled, evaluator-blinded (radiologist reviewer and physician evaluator) multicenter study to establish the superiority of a hyaluronan-based scaffold (Hyalofast®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions in comparison to control (microfracture treatment)

OA Knee

18 years of greater

A Multi-Center, Active-Controlled, Open-Label, Phase 2 Trial to Compare the Efficacy adn Safety of CartiLife, and Microfracture for Patients with Articular Cartilage Defects in the Knee