Effectiveness of Wharton's Jelly-derived Stem Cells in Patients With Osteoarthritis of the Knee, Hip or Glenohumeral Joint and Analysis of the Regeneration Processes Based on Inflammatory Markers, microRNAs and Clinical Features

NCT03866330 Phase 1/Phase 2 UNKNOWN

This phase I/II study will enroll 100 subjects with mild to moderate osteoarthritis of the hip/knee/ glenohumeral joint will be enrolled according to strict inclusion and exclusion criteria. Subjects will receive every three months a single dose of at least 10 million of Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) form the Polish Stem Cell Bank for 12 months (maximum four doses in total and at least 40 million of WJMSC in total) via ultrasound guided intra-articular injection.

Details

Lead sponsor	Medical University of Warsaw
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	100
Start date	2019-03-01
Completion	2022-03-01

Conditions

• Osteoarthritis
• Hip Osteoarthritis
• Knee Osteoarthritis
• Glenohumeral Osteoarthritis

Interventions

• Intraarticular injection of WJMSC

Primary outcomes

• HIP DISABILITY AND OSTEOARTHRITIS OUTCOME SCORE (HOOS) — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
  Change in HOOS score. HOOS consists of 5 subscales: pain, other symptoms, function in activities of daily living (ADL), and function in sport and recreation (Sport/Rec), and hip-related quality of life (QOL). In total, 40 items: 10 items for pain, 5 items for other symptoms (3 for symptoms and 2 for stiff- ness), 17 items for function in ADL, 4 items for function in Sport/Rec, and 4 items for hip-related QOL. Standardized answer options are given (5 Likert boxes) and each question is scored from 0 to 4. Scores are summarized for each subscale and trans- formed to a 0-100 scale (0 indicating extreme problems and 100 indicating no problems).
• Harris Hip Score — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
  Change in Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
• Knee injury and Osteoarthritis Outcome Score (KOOS) — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
  Change in KOOS score It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL) The five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.
• modified Harris Hip Score for knee — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
  Change in modified Harris Hip Score (HHS) The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
• The International Knee Documentation Committee (IKDC Questionnaire) — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)]
  Change in IKDC Questionnaire score The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
• WOMAC (for hip and knee) — Baseline (T0), 3 months (T1), 6 months (T2), 9 months (T3), 12 months (T4), 24 months (T5)
  Change in WOMAC score. WOMAC score is used to assess patients with osteoarthritis of the hip or knee using 24 parameters in 5 categories. 1 Pain 2.Stiffness 3.Physical function 4.Social function 5. Emotional function Scoring and Interpretation Response : points none - 0 slight 1 moderate 2 severe 3 extreme 4 score = = summary (points for relevant items) average score = = (total score) / (number of items) Interpretation: minimum total score: 0 maximum total score: 96 minimum pain subscore: 0 maximum pain subscore: 20 minimum stiffness subscore: 0 maximum stiffness subscore: 8 minimum physical function subscore: 0 maximum physical function subscore: 6

Countries

Poland