Regenerative therapies for upper limb functional recovery after stroke: study protocol of a randomized clinical trial.

BACKGROUND

Stroke-related long-term disability is primarily due to impaired motor function. Rehabilitation efforts have traditionally focused on central strategies while ignoring the affected muscles. Regenerative medicine approaches have emerged as a promising option for treating various conditions, including muscular disorders. The present study aims to compare the effects of intramuscular injections of mesenchymal stromal cells (MSCs) and Platelet-rich plasma (PRP) on motor recovery in poststroke survivors.

METHODS

A single-blind, randomized, controlled trial will be followed. Fifteen stroke patients who meet the eligibility criteria will be randomly assigned to the cell therapy, PRP, or waiting-list control groups. Patients in each group will receive a single injection of MSCs or PRP into their affected biceps brachii muscle. Patients in the waiting list control group will receive no intervention. The outcome measures include the Modified Modified Ashworth Scale (MMAS), Brunnstrom recovery stages for the upper limb, elbow range of motion, and sonographic evaluations. All outcome measures will be assessed at baseline, 1, 2, and 3 months after injection.

CONCLUSIONS

The findings of this study will provide initial supportive evidence regarding the efficacy of MSCs and PRP therapy in improving biceps brachii muscle spasticity and function in patients with chronic stroke.

TRIAL REGISTRATION: IRCT20230208057351N1.