Phase I trial to evaluate safety of Deferiprone-Chitogel to prevent epidural fibrosis in lumbar spine surgery.

BACKGROUND: Epidural fibrosis is a common consequence of lumbar decompression surgery and has been implicated in the recurrence of radicular pain. Chitogel, combined with the iron-chelating agent deferiprone, has shown anti-fibrotic properties in preclinical models. This study aimed to evaluate the safety and feasibility of Chitogel–Deferiprone application in lumbar spinal surgery, marking its first human use in a sterile surgical site. METHODS: This single-arm, Phase I pilot study enrolled 20 patients undergoing lumbar decompression surgery. The Chitogel–Deferiprone hydrogel was applied to 30 operative levels at the time of wound closure. Safety was assessed via postoperative complication monitoring, particularly for wound infection. Secondary outcomes included patient-reported outcomes using the Lumbar Spine Outcomes Questionnaire (LSOQ) and MRI assessment of epidural fibrosis at 3 months. A composite fibrosis score and a binary “extensive scarring” classification were used to quantify scar burden. Paired t-tests, correlation analyses, and independent t-tests were used to evaluate symptom changes and relationships to fibrosis severity. RESULTS: No deep wound infections or reoperations occurred during follow-up. One patient (5%) developed a superficial wound infection, consistent with expected postoperative complication rates. Of the 20 patients, 12 completed the 6-month LSOQ, showing significant improvements in back pain (42.4% reduction, p = 0.003), leg pain (49% reduction, p < 0.001), disability (34% reduction, p = 0.002), and physical symptoms (28.5% reduction, p = 0.037). MRI was completed in 14 patients (21 operative levels); 66% met Ross criteria for extensive scarring, although no correlation was found between fibrosis burden and symptom severity or improvement. CONCLUSION: This pilot study demonstrates that intraoperative application of Chitogel–Deferiprone in lumbar spine surgery is safe and feasible. Although improvements in symptoms were observed, no relationship between epidural fibrosis and postoperative pain was identified. These findings support the conduct of a larger, controlled trial to evaluate efficacy.