This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2 clinics on 135 knees.
Primary Objective: A Phase 1, open-label, non-controlled trial, to assess the safety of intra-articular injection of SIG001, at either of two doses, in a total of 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days after dosing. Secondary Objective: A Phase 1, open-label, non-controlled trial, to obtain very early data relating to any effects of intra-articular injection of SIG001, at either of two doses pain, activity, and quality of life in 10 patients with Symptomatic Osteoarthritis of the Knee, Kellgren-Lawrence Grade 2-3, at 7, 30, 90 and 180 days. Study Design: The Phase 1 trial will enroll 5 subjects into an initial group receiving a low dose of SIG001. Provided that these subjects tolerate this dose well, will proceed to enroll 5 subjects into a group receiving a high dose of SIG001.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Low dose - Subjects will receive SIG001 (75 mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate. High dose - Subjects will receive SIG001 (150mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate.
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Time frame: 7 days
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Time frame: 30 days
Evaluate the safety and tolerability of Signature Cord Prime as defined per CTCAE v. Stopping criteria as defined in 6.11.2.8
Administered as a single intra-articular injection in subjects with osteoarthritis of knee at 2 dose levels; 75mg and 150mg
Time frame: 90 days
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline: Changes in overall WOMAC Score (WOMAC)
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline: Changes in overall KOOS Score (KOOS)
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline: Changes in patient-reported outcomes (PROs) (PROMIS-29)
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Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline: Changes in the Pain Visual Analog Scale (100 mm VAS)
Time frame: 90 days and six months
Exploratory objective to observe for early data suggestive of efficacy by estimating and comparing changes from baseline
Changes are the differences from the baseline: Use of opioid analgesic during study for the affected knee
Time frame: 90 days and six months