NCT00221143

Brief Summary

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

First QC Date

September 13, 2005

Last Update Submit

February 6, 2009

Conditions

Leg PainUlcerGangreneIschemiaPeripheral Vascular Diseases

Keywords

Ulcer/ gangreneLeg diseasesPainVascular diseasesChronic limb ischemiaPeripheral artery disease

Outcome Measures

Primary Outcomes (1)

  • Major amputation

Secondary Outcomes (1)

  • Limb ischemia

Interventions

Autologous peripheral blood CD34 positive cell therapyGENETIC

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease)
  • Patients with luminal stenosis \> 50% by leg angiography
  • Age is between 20 and 80.
  • Patients whose Rutherford's class is II-4, III-5, or III-6（Patients with rest pain or ischemic ulcer/necrosis)
  • Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients)
  • Patients who can give informed consent themselves in writing.

You may not qualify if:

  • Left ventricular ejection fraction \< 25%
  • Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
  • Less than 6 months since last episode of myocardial/cerebral infarction.
  • Patients with unstable angina, with a treatment rating of 3 in the Braunwald system, but a severity of III and a clinical rating of B or C.
  • Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV).
  • Patients with malignant tumor
  • Patients with chronic rheumatoid arthritis.
  • Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  • Patients currently suffering from or having a history of interstitial pneumonitis.
  • Patients for whom cranial MRA reveals cerebral aneurysm.
  • Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
  • Patients with cirrhosis of the liver.
  • Patients who cannot discontinue Warfarin.
  • Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  • Platelets less than 100,000/µL.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kobe City General Hospital

Kobe, Hyōgo, 650-0046, Japan

Location

Institute of Biomedical Research and Innovation

Kobe, Hyōgo, 650-0047, Japan

Location

Related Publications (8)

  • Asahara T, Kawamoto A. Endothelial progenitor cells for postnatal vasculogenesis. Am J Physiol Cell Physiol. 2004 Sep;287(3):C572-9. doi: 10.1152/ajpcell.00330.2003.

    PMID: 15308462BACKGROUND

  • Kawamoto A, Tkebuchava T, Yamaguchi J, Nishimura H, Yoon YS, Milliken C, Uchida S, Masuo O, Iwaguro H, Ma H, Hanley A, Silver M, Kearney M, Losordo DW, Isner JM, Asahara T. Intramyocardial transplantation of autologous endothelial progenitor cells for therapeutic neovascularization of myocardial ischemia. Circulation. 2003 Jan 28;107(3):461-8. doi: 10.1161/01.cir.0000046450.89986.50.

    PMID: 12551872BACKGROUND

  • Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.

    PMID: 11156872BACKGROUND

  • Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner JM. Isolation of putative progenitor endothelial cells for angiogenesis. Science. 1997 Feb 14;275(5302):964-7. doi: 10.1126/science.275.5302.964.

    PMID: 9020076BACKGROUND

  • Takahashi T, Kalka C, Masuda H, Chen D, Silver M, Kearney M, Magner M, Isner JM, Asahara T. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization. Nat Med. 1999 Apr;5(4):434-8. doi: 10.1038/7434.

    PMID: 10202935BACKGROUND

  • Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, Li T, Isner JM, Asahara T. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci U S A. 2000 Mar 28;97(7):3422-7. doi: 10.1073/pnas.97.7.3422.

    PMID: 10725398BACKGROUND

  • Kinoshita M, Fujita Y, Katayama M, Baba R, Shibakawa M, Yoshikawa K, Katakami N, Furukawa Y, Tsukie T, Nagano T, Kurimoto Y, Yamasaki K, Handa N, Okada Y, Kuronaka K, Nagata Y, Matsubara Y, Fukushima M, Asahara T, Kawamoto A. Long-term clinical outcome after intramuscular transplantation of granulocyte colony stimulating factor-mobilized CD34 positive cells in patients with critical limb ischemia. Atherosclerosis. 2012 Oct;224(2):440-5. doi: 10.1016/j.atherosclerosis.2012.07.031. Epub 2012 Jul 27.

    PMID: 22877866DERIVED

  • Kawamoto A, Katayama M, Handa N, Kinoshita M, Takano H, Horii M, Sadamoto K, Yokoyama A, Yamanaka T, Onodera R, Kuroda A, Baba R, Kaneko Y, Tsukie T, Kurimoto Y, Okada Y, Kihara Y, Morioka S, Fukushima M, Asahara T. Intramuscular transplantation of G-CSF-mobilized CD34(+) cells in patients with critical limb ischemia: a phase I/IIa, multicenter, single-blinded, dose-escalation clinical trial. Stem Cells. 2009 Nov;27(11):2857-64. doi: 10.1002/stem.207.

    PMID: 19711453DERIVED

MeSH Terms

Conditions

UlcerGangreneIschemiaPeripheral Vascular DiseasesPainVascular DiseasesPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Takayuki Asahara, M.D.

    Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Study Completion

January 1, 2008

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

JP(2)