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Exploratory study of adipose-derived mesenchymal stem cell line-derived platelet like cells (ASCL-PLC) in patients with refractory chronic skin ulcer (Exploratory study of ASCL-PLC)

Safety and efficacy study of ASCL-PLC in patients with refractory chronic skin ulcer. (Safety and efficacy study of ASCL-PLC )

Matsumoto Morio

Obara Hideaki

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku, Tokyo

obara.z3@keio.jp

Kawai Kana

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-3353-1211

kana_kawai@keio.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who participate in the study must meet all the criteria shown below.
1) Between the ages of 20 and 85 (at the time of consent), regardless of their sex.
2) Providing written consent.
3) Being able to be followed up, and willing to adhere to the protocol related to the following-up.
4) Having three or fewer refractory chronic skin ulcers of the targeted limb, with the total area ranging from 0.1 cm^2 to 10 cm^2. (The shortest diameter of one ulcer site should be at least 1 mm.)
5) Having received or receiving standard therapy performed at Keio University Hospital, or being treated at other medical institutions with a full-time cardiovascular surgeon (Standard therapy includes local ointment, systemic medication, endovascular treatment or bypass surgery for ischemic ulcers; ointment or compression therapy for venous stasis ulcers).
6) Patients who ulcer area at screening is documented and ulcers with less than 50% improvement after 1 month of standard therapy performed at Keio University Hospital, or treatment performed at at other medical institutions with a full-time cardiovascular surgeon.

Patients who satisfy any of the criteria shown below will be excluded in the study.
1) With the value of SPP in the proximal margin of the targeted ulcer being 20 mm Hg or lower.
2) Having received trafermin or alprostadil alfadex within the last 7 days before the initiation of the treatment.
3) Continuously receiving immunosuppressive therapy including corticosteroids with poorly controlled underlying disease and unstable medical status (the receiving immunosuppressive therapy without dosage increase for at least one month prior to treatment is considered to be stable for the underlying disease. except for ointment, eye drops, and short-term use for asthma).
4) Receiving hemodialysis.
5) Having severe liver dysfunction, renal impairment, cardiovascular diseases, lung diseases, hematological diseases or metabolic diseases and considered to be inappropriate for the study by a lead investigator or other investigators.
6) Having diabetes with the value of HbA1c being 9.0% or higher, even after the medication.
7) Having developed acute myocardial infarction or cerebrovascular disease within the last 30 days before the initiation of the treatment.
8) Having cancer, or having been diagnosed with advanced cancer within 5 years before the case enrollment.
9) Breastfeeding, being pregnant, or could be pregnant. Patient who hopes to bear child, or who could not keep contraception.
10) Being enrolled in other clinical studies which aim for the treatment.
11) Having mental disorder or psychiatric symptoms, and considered to be inappropriate for the study.
12) Having a history of severe allergic reaction caused by the administration of cell therapy including blood transfusion.
13) Having an allergy to animals (cattle).
14) Having an allergy to streptomycin sulfate, amphotericin B, or penicillin.
15) Considered to be inappropriate for the study for various reasons by the lead investigator or other investigators.
16) Having an ulcer with an uncontrollable infection which needs antibiotics administration (Grade 2 or higher). (Prophylactic antibiotics are excluded. )

Both

refractory chronic skin ulcer

To give the specific cell product in addition to the standard therapy (medication, endovascular treatment or bypass surgery for ischemic ulcers, compression therapy for venous stasis ulcers), to the patient with refractory chronic skin ulcers.

Safety evaluation: Frequency of adverse events

Efficacy evaluation:
1) Ulcer size reduction rate from day 0
2) Complete epithelialization rate
3) Pain score by Numerical Rating Scale (NRS)
4) Value of skin perfusion pressure (SPP)
5) Measured value by laser Doppler blood flow meter
6) Value of ankle-brachial index (ABI)
7) EQ-5D

Not Recruiting

+81-3-5363-3503

Jan. 24, 2020

No

none