Safety and Efficacy of Intravenous ExoFlo in the Treatment of Complex Regional Pain Syndrome.

BACKGROUND

Complex regional pain syndrome (CRPS) is an extremely painful disorder driven primarily by inflammation.

OBJECTIVES

We hypothesized that the immunomodulatory biologic, ExoFloTM, composed of bone marrow mesenchymal stem cell-derived extracellular vesicles, could be safely administered to CRPS patients and alleviate symptoms.

STUDY DESIGN

Ten patients received 2 intravenous (IV) infusions, each containing 15 mL ExoFlo, on day one and day 4. A series of tests were performed at baseline (day 0, prior to infusion), week one, and months one, 3, and 6 after the second infusion.

SETTING

All patients were treated in one of 2 outpatient pain management clinics in Orange County, CA.

METHODS

Testing for clinical improvement included: visual analog scale of pain, brief pain inventory, 36-item short-form questionnaire, range of motion analysis, and jamar dynamometer testing.

RESULTS

No serious adverse events related to ExoFlo treatment occurred. Statistically significant improvements in pain and motion assessments occurred across the patient pool.

LIMITATIONS

This study was limited by its patient number enrolled (10), it lacked a control arm, and one patient who dropped out of the study.

CONCLUSIONS

IV delivery of ExoFlo appears safe in patients with CRPS. In addition, ExoFlo exhibited efficacy in addressing CRPS symptoms. Given the lack of effective and safe treatments available to CRPS patients, these results suggest that further studies are warranted to explore and validate this potential treatment for CRPS.