UMIN-CTR Clinical Trial

Public title

Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Acronym

Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Scientific Title

Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Scientific Title:Acronym

Multiple dose regenerative therapy using ex vivo expanded autologous peripheral mononuclear cells (MNC-QQ) for patients with non-healing ischemic hindlimb wound -Phase1/2 Study-

Region

Japan

Condition

non-healing ischemic hindlimb 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 monomuclear cells for patients with non-healing ischemic hindlimb wound.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety

Key secondary outcomes

Efficacy

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, 1x10^7 cells

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 written informed consent.
2. Patients are at the age of 20 to 75 at the time of informed consent.
3. Patients with Atherosclerotic PAD with >70% luminal stenosis in the leg arteries by digital subtraction angiography.
4. Patients who developed chronic hindlimb ischemia more than three months ago before having informed consent.
5. Patients of Rutherford classification, category 5.
6. Patients without adaptation for transluminal angioplasty or stenting and bypath surgery.

Key exclusion criteria

1. Patients of Rutherford classification, category 6.
2. Patients with wound on heel.
3. Patients with Buerger's disease.
4. Patients with treatments of angioplasty, bypath surgery or LDL-apheresis for expecting leg for cell transplantation within a month.
5. Patients with HbA1c more than 8.0 with the medication for diabetes.
6. Patients with severe systemic infection.
7. Patients with severe anemia.
8. Patients with major amputation of another leg.
9. Patients with NYHA3 or 4, or Left ventricular ejection fraction< 25%.
10. Patients who have treatment with anti-angiogenic medicine for proliferative diabetic retinopathy and other disease.
11. Patients have malignancy, or within 5 years after recover from malignant tumor (10 years after breast cancer), except for cutaneous basal cell carcinoma.
12. Patients with hematopoietic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome.
13. Pregnant women, lactating women, female patients who may be pregnant, and who plan the pregnancy by the end of the observation period.
14. Patients infected with HIV, active HBV, HCV, HTLV, or syphilis in screening test.
15. Patients not expecting live for a year or more.
16. Patients enrolled in any other clinical trial within 90 days before informed consent.
17. Any other reason that the Clinical Researchers may have for considering a case unsuitable for the study.

Target sample size

7

Name of lead principal investigator

1st name
Middle name
Last name	Rica Tanaka

Organization

Juntendo Univeristy 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@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Rica Tanaka

Organization

Juntendo Univeristy 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@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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

2018

Year

11

Month

15

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

Enrolling by invitation

Date of protocol fixation

2018

Year

09

Month

25

Day

Date of IRB

Anticipated trial start date

2018

Year

09

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

05

Day

Last modified on

2018

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039483