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A study of Platelet rich plasma(PRP) therapy for refractory ulcer (A study of Platelet rich plasma(PRP) therapy for refractory ulcer)

A study of PRP therapy (A study of PRP therapy)

Ito Tohru

Dec. 01, 2020

1

40s, Female, Disease name: Refractory ulcer (left lower leg) Background:Injured open fracture of left lower leg, peripheral neuropathy of lower limbs, it was intractable even after the usual treatment. Patient meets the selection criteria of this study and is related to the treatment with sufficient explanation and understanding. This treatment was performed after obtaining written consent.

The patient's own blood is collected and PRP is obtained by an automated autologous platelet centrifuge (Magellan; Artetiocyte Medical Systems, Inc., Cleveland, USA). The area of ulcer and the amount of blood collected are 30 to 60 mL of blood collected for 10 x 10 cm of ulcer in general adults, and about 3 to 6 mL of platelet-rich plasma (PRP) can be obtained from this. As a local treatment, the necrotic tissue on the ulcer surface is removed to the extent possible to refresh the wound surface, and then PRP is applied to the wound or immersed in a wound dressing. If there is severe pain when removing necrotic tissue, it is performed under local anesthesia. Cryopreserved PRP was used from the second PRP onward. Frozen PRP was naturally thawed and administered in the same manner.

No findings that could lead to exacerbation of symptoms were identified.

Platelet-rich plasma (PRP) was administered to one female (40s) intractable ulcer (left thigh) during the year from March 6, 2019 to March 5, 2020. The selection criteria for this therapy, including patient background and symptoms, were observed. No deviation was found. No adverse events such as redness, exudate volume, bleeding, or pain associated with PRP administration were observed, and the area reduction rate from the first administration to 6 months after the final administration was 70% or more even in the follow-up after administration. No findings leading to exacerbation of symptoms were found. The ulcer gradually shrank, leaving only a linear ulcer 6 months after the final dose. Summarizing the above, it is considered that the safety of the regenerative medicine is sufficiently high. In this regenerative medicine study for refractory ulcers, it is considered to be scientifically valid from the image findings and the tendency of improvement of symptoms. Follow up observation will be continued as much as possible.

40s, Female, Disease name: Refractory ulcer (left lower leg)Injured open fracture of left lower leg, peripheral neuropathy of lower limbs, intractable even after the usual treatment. On March 26, 2019, according to the protocol, PRP was prepared, immersed in artificial dermis (terdermis), and attached to the ulcer. A linear ulcer left 6 months after the final dose. The area reduction rate was 70% or more. PRP was effective in treating intractable ulcers.

Nov. 29, 2021

https://jrct.mhlw.go.jp/latest-detail/jRCTc040190121

Shimada Kenichi

Kanazawa Medical University Hospital

1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN

shimaken@kanazawa-med.ac.jp

Masuda Naomi

Kanazawa Medical University Hospital

1-1 Daigaku, Uchinada, Kahoku, Ishikawa 920-0293, JAPAN

+81-76-218-8200

regene@kanazawa-med.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with refractory skin ulcers that are not improved or are
exacerbated by conventional treatments, and who are difficult to treat
by surgery due to physical condition, etc. Patients over 20 years of age
who have obtained a written consent of their own free will

(1)Refractory ulcer resistant to conservative treatment
(2)Patients who refuse to undergo surgical procedures such as amputation
and skin grafting, or patients whose general condition is poor enough
for the anesthesiologist to determine that the surgery is inappropriate
(3)Patients who can collect blood for PRP preparation
(4)Being an adult over 20 years old
(5)Patients who have obtained written consent from the subject (or
surrogate) before collecting blood for PRP preparation

Patients with advanced anemia, thrombocytopenia, etc., who are judged
inappropriate as subjects by the investigator
(1)Patients who have wound surface with uncontrollable infection (if the
infection is suspected due to the color of the wound, the color of the
pus, or the smell, the presence of infection is determined by culturing
the bacteria)
(2)Patients with malignant tumor on the wound surface (ulcer)
(3)Significant anemia (Hb <7g / dL for both men and women)
(4)leukemia
(5)Aplastic anemia
(6)Thrombocytopenia
(7)Patients diagnosed with abnormal blood coagulation

Both

refractory ulcer

The patient's own blood is collected and PRP is obtained by an automated
autologous platelet centrifuge (Magellan; Arteriocyte Medical Systems,
Inc., Cleveland, USA). In general adults, for 10 x 10 cm target ulcer,
blood collection volume is 30-60 mL, and approximately 3-6 mL of
platelet-rich plasma (PRP) is obtained.
As a local treatment, after removing the necrotic tissue on the ulcer
surface as much as possible and renewing the wound surface, PRP is
applied to the wound part or immersed and applied to the wound dressing.
If patient complains severe pain in removing the necrotic tissue, the
necrotic
tissue is removed under local anesthesia. The series of operations from
blood collection, PRP
separation, and local treatment will be performed in the central
operating room.
Although local anesthetics are sometimes used to remove necrotic tissue,
the burden on the patient is small compared to conventional skin
transplantation and flap arthroplasty, and this is a treatment that can
be performed in most cases.
For the second and subsequent doses of PRP, use cryopreserved PRP.
Frozen PRP is naturally thawed and administered in the same manner.

refractory ulcer, Platelet rich plasma

Response rate: The response rate is calculated by defining a case where
the area reduction rate at the final visit during the PRP implementation
period exceeds 50% before the start of this study as a response.
* Since the reduction of the wound area is the primary goal for
treatment of intractable skin ulcers, the evaluation index for the area
reduction rate was set with reference to information on the approved
preparations for treatment of pressure ulcers and skin ulcers. The ulcer
area reduction rate is also calculated and evaluated.

Evaluate changes in ulcer area and properties at the time of each
observation (diagnosis after 1 week, 4 weeks, 3 months, and 6 months
after administration).

Evaluate the safety of PRP therapy (adverse events, serious adverse
events, frequency of failures).

Complete

+81-76-218-8200

Feb. 24, 2017