UMIN-CTR Clinical Trial

Public title

Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-

Acronym

Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-

Scientific Title

Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-

Scientific Title:Acronym

Regenerative cell therapy of ex vivo expanded autologous peripheral mononuclear cells for patients with non-healing wound -phase I study-

Region

Japan

Condition

non-healing wound

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For confirmation of safety of cell therapy of in vitro cultured autologous peripheral mononuclear cells for patients with non-healing wound after more than one month of conventional therapy.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety

Key secondary outcomes

wound heling

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ex vivo expanded autologous peripheral mononuclear cells, 2 x 10^7 cells,within 20sites surround 20cm around the wound. subcutaneous or intramuscular injection

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1 Patients with severe wound more than Grade 1 of Wagner classification and our ulcer classification of Grade 3, who are resistant to the conventional therapy for more than a month and cannot expect improvement.
2 Patients who not improved wound with medical treatment for a month.
3 Patients are at the age of 20 to 75 at the time of informed consent

Key exclusion criteria

1 Patients showed more than 60% of wound recover by conventional therapy.
2 Patients with HbA1C more than 8.0% with the medication for diabetes.
3 Patients with total occlution of all major artery in hindlimb.
4 Patients with high cardiac hypofunction with ultrasonic cardiogram with left ventricle ejection fraction less than 25%.
5 Patients with the high coronary lesion which needs treatment.
6 Patients with malignant tumor and proliferative diabetic retinopathy .and other compliated malignat ischemic disease
7 Patients who cannot expect the remaining days more than one year for some kind of causes except the ischemia disease.
8 Patients with myocardial infarction or cerebral infarction onset within six months.
9 Patients with hematologic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome.
10 Patients with anemia (hemoglobin concentration less than 10.0 g/dL).
11 Patients with the severe respiratory functional disorder or impairment of liver function.
12 Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period.
13 Patients without informed consent.
14 Patients infected with HIV, HCV, HBV, HTLV or parvovirus B19.
15 Patients who are judged to be inappropriate to participate based on medical proof by a responsibile doctor or contributed doctors of this clinical study.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Rica Tanaka

Organization

Juntendo University School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

rtanaka@juntenndo.ac.jp

Name of contact person

1st name
Middle name
Last name	Rica Tanaka

Organization

Juntendo University School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

rtanaka@juntenndo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Japan Agency for
Medical Research and development, AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

02

Month

28

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019241