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PRP therapy (PRPT)

PRP therapy (PRPT)

Akira Hara

Nov. 04, 2020

7

The median age was 37 year-old (22 to 62 year-old), 2 males and 5 females, 2 digital nerve injuries, 2 ulnar nerve injuries at forearm, and 3 brachial plexus injuries.

The pace of patient registration was less than initially expected because of small number of target patients with peripheral nerve injury. Peripheral nerve injury patients who met the inclusion criteria without exclusion criteria were also small. All 7 patients completed all evaluations until the end of the observation period.

No adverse events related to PRP administration was observed.

In this study, we verified the adverse events related to local PRP administration during the observation period as the primary endpoint of safety. The quality of the prepared PRP was measured with an automatic blood cell measuring device immediately after the preparation, and it was confirmed that the prepared PRP in all cases met the standard criteria. Furthermore, no bacterial contamination was observed by a bacterial culture test. Adverse events were defined as wound infections occurred up to 2 weeks after surgery. There were no cases of wound infections after surgery, and adverse events related to local PRP administration by the end of the observation period. In the secondary endpoint, the muscle strength of the repaired nerve innervating muscle improved in all 5 cases for which the manual muscle strength test could be evaluated. In all 5 cases for which Tinel's sign could be evaluated, the site of Tinel's sign extended distally after surgery, and 2 of them became negative (cured). The platelet concentration rate of the prepared PRP was 1.6 times on average. Although the symptoms suggesting nerve regeneration after surgery were observed all patients, the usefulness of PRP for nerve regeneration could not be verified because it was not a comparative study.

Our result suggested that local administration of PRP to nerve repair site during nerve repair surgery for patients with peripheral nerve injury is safe without causing adverse events related to PRP. In order to verify the usefulness of local PRP administration for nerve regeneration, a prospective comparative study is necessary in the future.

April. 01, 2021

Sept. 20, 2018

https://pubmed.ncbi.nlm.nih.gov/30327740

No

NA

https://jrct.mhlw.go.jp/latest-detail/jRCTc030190219

Hara Yuki

Tsukuba University Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

yukihara@md.tsukub.ac.jp

Yuki Hara

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibarali 3058576, Japan

+81-29-853-3219

yukihara@md.tsukuba.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who injured peripheral nerve over 20 years old male and female
Patients whose injury situation and injury site were revealed
Patients who can completed all study schedule

The patients who had suffered infection.The diabetic patient who is under medication.The patient who have collagen disease. The patient who have bood system disorder. The patient who have anemia. The patient who have used anticoagulant. The patient who have used steroids within 3 months. The patient who has a doubt or diagnostic neoplastic lesion within 5 years before agreement. The patient who has not ability for agreement with own will. The patient who has not ability for agreement by the reading and writeing The patient who has been judged to be inappropriate as a subject by the doctor incharge.

Both

peripheral nerve injury

PRP is dispendide after peripheral blood aspiration and contrifuge. PRP is injected on repaire site of injured peripheral nerve.

120

Incidence of all adverse events that occurred during the clinical trials

Nerve regeneration( MMT, Semmes-Weinstein monofilament test,Tinel sign) Electromyography
Evluation of PRP(Blood cell number, Concentlation of Growth factor)

Complete

+81-29-853-3914

Mar. 09, 2017