| NCT04612023 |
Acellular Amniotic Membrane |
Phase 2;
N = 90 |
-
(1)
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires (timeframe: 1 year)—Knee injury and Osteoarthritis Outcome Score (KOOS)—assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
-
(2)
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires (timeframe: 1 year)—Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)—assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It is a 0 (worst) –96 (best scale.
-
(3)
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires (timeframe: 1 year)—Visual Analogue Scale (VAS)-assess pain, It is a 0–100 scale. A higher score indicates greater pain intensity.
|
Recruiting |
USA |
| NCT04636229 |
Amniotic suspension (Amniotic membrane + amniotic fluid-derived cells) |
Phase 3;
N = 474 |
-
(1)
The difference in change from baseline in WOMAC pain scale at 6 months between ASA- and placebo-treated patients (timeframe: baseline to week 26)—The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0–4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
|
Recruiting |
USA |
| NCT03441607 |
Micronized human amnion chorion membrane |
Phase 2;
N = 320 |
|
Unknown |
USA |
| NCT04886960 |
Amniotic Fluid |
Phase 1/2;
N = 60 |
-
(1)
Repeat allogeneic intra-articular injection within 6 months (timeframe: 6 months)—Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e., SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study’s electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
|
Recruiting |
USA |
| NCT04698265 |
Amniotic suspension (Amniotic membrane + amniotic fluid-derived cells) |
Not applicable; N = 150 |
-
(1)
Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1, 3, 6, 12 months (timeframe: baseline, 1 week, 1, 3, 6, 12 months)—WOMAC is a self-administered questionnaire consisting of 24 items divided into three subscales: (1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright (2) Stiffness (2 items): after first waking and later in the day(3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting on/off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0–4, which correspond to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
|
Not yet recruiting |
Taiwan |
