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).

Retrospective studies - utility and caveats.

A thorough understanding of the pros and cons of the various study designs is critical to correct interpretation of their results. Retrospective studies are an important tool to study rare diseases, manifestations and outcomes. Findings of these studies can form the basis on which prospective studies are planned. Retrospective studies however have several limitations owing to their design. Since they depend on review of charts that were originally not designed to collect data for research, some information is bound to be missing. Selection and recall biases also affect the results and reasons for differences in treatment between patients and lost follow ups can often not be ascertained and may lead to bias. Readers need to critically evaluate the methods and carefully interpret the results of retrospective studies before they put them to practice. Researchers should avoid over generalisation of results and be cautious in claiming cause-effect relationship in retrospective studies.

Super vasomol hair dye poisoning.

Hair dye poisoning is not rare but is an emerging poisoning in India. The main component of hair dye causing toxicity is paraphenylenediamine (PPD). Acute poisoning by PPD causes characteristic severe angioedema of the upper airway accompanied by a swollen, dry, hard, and protruding tongue. Systemic intoxication results in multisystem involvement and can cause rhabdomyolysis, acute renal failure (ARF). PPD consumption is an uncommon cause of ARF. There is no specific antidote for PPD and treatment is mainly supportive. We report a case of suicidal ingestion of hair dye that presented with cervicofascial edema and later developed rhabdomyolysis and ARF. Our patient improved with dialysis and symptomatic management.

Proteus syndrome: A rare case report.

Proteus syndrome (PS) is a rare hamartomatous disorder characterized by various cutaneous and subcutaneous lesions, including vascular malformations, lipomas, hyperpigmentation, and several types of nevi. Partial gigantism with limb or digital overgrowth is pathognomonic of PS. We report a rare case of PS in a 50-year-old man who presented with inferior wall myocardial infarction and was incidentally detected to have hypertrophy of index and middle fingers of both the hands.