UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010799
Receipt number R000012642
Scientific Title Hematopoietic stem cell transplantation for patients with ischemic limbs
Date of disclosure of the study information 2013/05/24
Last modified on 2016/03/02 12:15:10

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Basic information

Public title

Hematopoietic stem cell transplantation for patients with ischemic limbs

Acronym

Therapeutic angiogenesis

Scientific Title

Hematopoietic stem cell transplantation for patients with ischemic limbs

Scientific Title:Acronym

Therapeutic angiogenesis

Region

Japan


Condition

Condition

Patients with intractable ulcers caused by collagen diseases

Classification by specialty

Medicine in general Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effectiveness and tolerability of angiogenesis by autologous transplantation of bone marrow-derived cells in patients with ischemic limbs

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of gangrene and reduction of ulcer size

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Under general anesthesia, about 500-700 ml of bone marrow cells are collected from the ilium and mononuclear cells are separated on a centrifugal blood-cell separator. After separation, cells are concentrated by centrifugation. The cells are immediately implanted by intramuscular injection into an ischemic limb. In practice, we injected 0.5 ml of cells with
a 20-gauge needle 50 times at even intervals into an ischemic limb.

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with collagen diseases are eligible
for the study if they have nonhealing ischemic ulcer caused by vasculopathy and their ulcers are resistant to conventional therapy.

Key exclusion criteria

We exclude patients with severe
involvement of the lung and heart.
We also exclude patients with active retinopathy due to diabetes mellitus, with evidence of malignant disorder during the past 5 years, or with history of cerebral stroke during the past a year. Patients with a history of alcohol and/or drug dependency during the past 3 months are also excluded.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Ishigatsubo

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Internal Medicine and Clinical Immunology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2630

Email

ishigats@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryusuke Yoshimi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Internal Medicine and Clinical Immunology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2630

Homepage URL


Email

yoshiryu@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Internal Medicine and Clinical Immunology
Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 05 Month 24 Day

Last modified on

2016 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012642


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name