Efficacy and Safety of Stempeucel in Osteoarthritis of the Knee: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled Study.

BACKGROUND: Osteoarthritis is a chronic, progressive, and degenerative condition with limited therapy options. Recently, biologic therapies have been an evolving option for the management of osteoarthritis. PURPOSE: To assess whether allogenic mesenchymal stromal cells (MSCs) have the potential to improve functional parameters and induce cartilage regeneration in patients with osteoarthritis. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 146 patients with grade 2 and 3 osteoarthritis were randomized to either an MSC group or placebo group with a ratio of 1:1. There were 73 patients per group who received either a single intra-articular injection of bone marrow-derived MSCs (BMMSCs; 25 million cells) or placebo, followed by 20 mg per 2 mL of hyaluronic acid under ultrasound guidance. The primary endpoint was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. The secondary endpoints were WOMAC subscores for pain, stiffness, and physical function; the visual analog scale score for pain; and magnetic resonance imaging findings using T2 mapping and cartilage volume. RESULTS: Overall, 65 patients from the BMMSC group and 68 patients from the placebo group completed 12-month follow-up. The BMMSC group showed significant improvements in the WOMAC total score compared with the placebo group at 6 and 12 months (percentage change: -23.64% [95% CI, -32.88 to -14.40] at 6 months and -45.60% [95% CI, -55.97 to -35.23] at 12 months P < .001; percentage change, -44.3%). BMMSCs significantly improved WOMAC pain, stiffness, and physical function subscores as well as visual analog scale scores at 6 and 12 months (P < .001). T2 mapping showed that there was no worsening of deep cartilage in the medial femorotibial compartment of the knee in the BMMSC group at 12-month follow-up, whereas in the placebo group, there was significant and gradual worsening of cartilage (P < .001). Cartilage volume did not change significantly in the BMMSC group. There were 5 adverse events that were possibly/probably related to the study drug and consisted of injection-site swelling and pain, which improved within a few days. CONCLUSION: In this small randomized trial, BMMSCs proved to be safe and effective for the treatment of grade 2 and 3 osteoarthritis. The intervention was simple and easy to administer, provided sustained relief of pain and stiffness, improved physical function, and prevented worsening of cartilage quality for ≥12 months. REGISTRATION: CTRI/2018/09/015785 (National Institutes of Health and Clinical Trials Registry-India).

Commitment among state health officials & its implications for health sector reform: lessons from Gujarat.

BACKGROUND & OBJECTIVE: Commitment, competencies and skills of people working in the health sector can significantly impact the performance and its reform process. In this study we attempted to analyse the commitment of state health officials and its implications for human resource practices in Gujarat. METHODS: A self-administered questionnaire was used to measure commitment and its relationship with human resource (HR) variables. Employee's organizational commitment (OC) and professional commitment (PC) were measured using OC and PC scale. Fifty five medical officers from Gujarat participated in the study. RESULTS: Professional commitment of doctors (3.21 to 4.01) was found to be higher than their commitment to the organization (3.01 to 3.61). Doctors did not perceive greater fairness in the system on promotion (on the scale of 5, score: 2.55) and were of the view that the system still followed seniority based promotion (score: 3.42). Medical officers were upset about low autonomy in the department with regard to reward and recognition, accounting procedure, prioritization and synchronization of health programme and other administrative activities. INTERPRETATION & CONCLUSION: Our study provided some support for positive effects of progressive HR practices on OC, specifically on affective and normative OC. Following initiatives were identified to foster a development climate among the health officials: providing opportunities for training, professional competency development, developing healthy relationship between superiors and subordinates, providing useful performance feedback, and recognising and rewarding performance. For reform process in the health sector to succeed, there is a need to promote high involvement of medical officers. There is a need to invest in developing leadership quality, supervision skills and developing autonomy in its public health institutions.