Abstract

BACKGROUND CONTEXT Pressure injuries (PIs) are a common yet challenging problem especially in people with spinal cord injury (SCI) because of immobility and anesthetic skin. They are difficult to treat with standard medical care and often recur. Recent interest in the treatment of chronic wounds like PIs has shifted from the type of dressing with or without pharmaceutical topical agents to different therapies like negative pressure wound therapy (NPWT), gene therapy and stem cell based therapies. The rationale behind the use of cell-based therapies is the fact that cells in chronic wounds are phenotypically altered or senescent or both. Therefore, they have a limited capacity to divide and are less responsive to stimulation by growth factors. Promising results have been reported in the treatment of small series of mainly chronic lower-extremity wounds with bone marrow-derived stem cells (BM-MNC). PURPOSE The purpose of this pilot study was to obtain the preliminary data on the use of autologous bone marrow derived mononuclear cells (BM-MNCs) to treat PIs in terms of clinical outcome and procedure safety. STUDY DESIGN/SETTING Pilot study. PATIENT SAMPLE We enrolled individuals with SCIs aged 16 to 60 years with stage 3-4 PIs. Ten Spinal cord injury (SCI) cases were recruited; five cases received autologous bone marrow derived mononuclear cells (BM-MNCs) therapy and five standard wound care. OUTCOME MEASURES Surface area and depth of PI, exudate volume and formation of granulation tissue. METHODS About 3 hours before cell therapy, autologous bone marrow (BM) (100 ml) was obtained from the posterior iliac crest aspiration. Mononuclear cells (MNCs) were separated from bone marrow using plasma expresser. The BM-MNCs suspension was injected into the wound bed by 1 ml syringe. For injection, the wound was subdivided with a grid into small areas of 1 cm2. Infusion was performed into the wound bed as well as subdermally at the borders of the wound. Wound dressings during the entire study period were performed with moist gauzes twice a day and followed up to 9 weeks. RESULTS Physical wound healing outcomes were compared at weeks 3, 6, and 9. Significantly reduced surface area of PI in the BM-MNC treated group was observed at week 6 (p=0.04) and at week 9 (p=0.001) as compared to the standard wound care group. Similarly, significant reduction of depth was observed in the BM-MNC group at week 9 (p CONCLUSIONS The procedure of BM-MNC therapy was safe and well tolerated by the subjects. The efficacy can be better assessed with a larger sample size. But in this study, the results were highly satisfactory. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

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