Allogeneic umbilical cord blood-derived mesenchymal cells for synovitis in horses

This study, “Use of allogeneic umbilical cord blood-derived mesenchymal cells for treatment of synovitis in horses: an efficacy study,” is sponsored by eQcell Inc., and is facilitated by the Orthopaedic Research Center and equine sports medicine service at the Johnson Family Equine Hospital.

Purpose of the study

To evaluate the efficacy and dosing of a single administration of frozen allogeneic mesenchymal cells at a dose of either 10 million activated (stimulated) umbilical-derived mesenchymal stromal cells or 10 million nonactivated (unstimulated) umbilical-derived mesenchymal stromal cells for the treatment of synovitis in the carpus or front or hind fetlock of client-owned horses.

Study protocol

• Qualified horses will be referred to CSU’s Veterinary Teaching Hospital or the partnering clinic, VetweRx Equine Group. 24 horses will be enrolled for treatment and randomly placed into 2 treatment groups.
• Horses will receive physical and lameness exams with flexion tests prior to admission into the study. Full radiograph exam will also be performed.
• At the clinic, horses will receive a single injection of either 10 or 20 million allogeneic eCB-MSCs into the target joint.
• Follow-up physical and lameness exams will occur at 3- and 6- weeks post-injection.
• Detailed exercise and rehabilitation instructions for the initial 6 weeks following injection will be supplied to the client, based on Day 1 examination findings. An owner questionnaire will be provided to be answered 12- and 18-weeks post-injection to determine the level of work the horse is at, and if any adverse reactions occurred at home.

Owner responsibilities

• Qualified horses will be referred to CSU’s Johnson Family Equine Hospital or the partnering clinic, VetweRx Equine Hospital. 24 horses will be enrolled for treatment and randomly placed into 2 treatment groups.
• Horses will receive physical and lameness exams with flexion tests prior to admission into the study. Full radiograph exam will also be performed.
• At the clinic, horses will receive a single injection of either 10 or 20 million allogeneic equine cord blood-derived mesenchymal cells into the target joint.
• Follow-up physical and lameness exams will occur at 3 and 6 weeks post-injection.
• Detailed exercise and rehabilitation instructions for the initial 6 weeks following injection will be supplied to the client, based on Day 1 examination findings. An owner questionnaire will be provided to be answered 12 and 18 weeks post-injection to determine the level of work the horse is at, and if any adverse reactions occurred at home.