NCT01408381

Brief Summary

Phase II Clinical Trial, a prospective, multicenter, open, randomized, parallel-group controlled with three levels of dose. The hypothesis of the test we propose is that the mononuclear cells of bone marrow provide progenitor cells with regenerative capacity and besides secrete several angiogenic factors, and their implantation into ischemic tissues with both elements should contribute to angiogenesis and tissue regeneration with recovery of the circulation in the affected limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach
1 country

5 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

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

4.4 years

First QC Date

August 1, 2011

Last Update Submit

March 15, 2016

Conditions

Critical Limb Ischemia (CLI)

Keywords

Critical Limb Ischemia (CLI)Cell TherapyBone marrow mononuclear cells

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    6 months

Secondary Outcomes (6)

  • Ankle-brachial index

    1 month, 3 months, 6 months

  • Transcutaneous oxygen pressure (TcO2)

    1 month, 3 months, 6 months

  • Greater ulcer size

    1 month, 3 months, 6 months

  • Degree of Rutherford-Becker

    1 month, 3 months, 6 months

  • Perimeter calf muscle

    1 month, 3 months, 6 months

  • +1 more secondary outcomes

Study Arms (4)

Control

NO INTERVENTION

No cell therapy

Low dose

EXPERIMENTAL

Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells: 1 x 108

Other: Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells

Intermediate dose

EXPERIMENTAL

Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells: 5 x 108

Other: Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells

High dose

EXPERIMENTAL

Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells: 1 x 109

Other: Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells

Interventions

Intraarterial Infusion of Autologous Bone Marrow Mononuclear CellsOTHER

Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x108, 5x108 and 1x109 low, intermediate and high dose in the arms respectively.

High doseIntermediate doseLow dose

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes aged ≥ 18 and ≤ 89 years.
  • Non-diabetic.
  • Infrapopliteal atherosclerotic vascular disease with severe to severe claudication or Rutherford-Becker grade I-3, II, III, in at least one lower limb. The chronic critical ischemia of the lower limb is defined as persistent / recurring pain requiring analgesia and / or non-healing ulcers present\> 4 weeks, with no evidence of improvement with conventional therapies and / or walking test (stress test) between 1-6 minutes two exercise tests separated by at least 2 weeks and / or ankle-brachial index at rest \<0.8.
  • Inability to endovascular or surgical revascularization as recommended by the TransAtlantic Inter-Society Consensus (TASC).
  • Failure of the revascularization surgical performed at least 30 days before, either persistently or entry in critical ischemia phase.
  • Life expectancy\> 2 years.
  • Normal laboratory parameters, defined by:
  • Leukocytes ≥ 3000
  • Neutrophils ≥ 1500
  • Platelets ≥ 100,000
  • Aspartate aminotransferase AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution.
  • Creatinine ≤ 2.5 mg / dl
  • Patients should give their written informed consent to participate in the study.

You may not qualify if:

  • History of malignancy or hematologic disease (myeloproliferative disease, myelodysplastic syndrome or leukemia)
  • Patients with uncontrolled hypertension (defined as blood pressure\> 180/110 on more than one occasion).
  • Severe heart failure (New York Heart Association IV).
  • Patients with malignant ventricular arrhythmias or unstable angina.
  • Diagnosis of deep vein thrombosis in the previous 3 months.
  • Active infection or gangrene wet day infusion of mononuclear bone marrow cells.
  • Corporal mass index (BMI)\> 40 kg/m2.
  • Proliferative retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Reina Sofía

Córdoba, Cordoba, 14004, Spain

Location

University Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

University Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

University Hopistal Carlos Haya

Málaga, Málaga, 29010, Spain

Location

University Hospital Nuestra Señora de Valme

Seville, Sevilla, 41014, Spain

Location

Related Links

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Inmaculada Herrera, MD, PhD

    University Hospital Reina Sofía, Córdoba.

    STUDY CHAIR

  • Antonio Chacon, MD, PhD

    University Hospital Reina Sofia, Córdoba

    PRINCIPAL INVESTIGATOR

  • Diego Martinez, MD, PhD

    University Hospital Morales Meseguer, Murcia

    PRINCIPAL INVESTIGATOR

  • Jose P Linares, MD, PhD

    University Hospital San Cecilio, Granada

    PRINCIPAL INVESTIGATOR

  • Vicente Garcia, MD, PhD

    University Hospital Virgen de las Nieves, Granada

    PRINCIPAL INVESTIGATOR

  • Andres Garcia, MD, PhD

    University Hospital Nuestra Señora de Valme, Sevilla

    PRINCIPAL INVESTIGATOR

  • Manuel Piñero, MD, PhD

    University Hospital Puerta del Mar, Cádiz

    PRINCIPAL INVESTIGATOR

  • Fernando Calleja, MD, PhD

    University Hospital Carlos Haya, Málaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

ES(5)