Clinical Trial Results:
Phase II Clinical Study on Therapeutic Angiogenesis with Mononucleated Autologous Bone Marrow Cells in Diabetic Patients with Chronic Critical Ischemia of non-revascularizable lower limbs
Summary
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EudraCT number |
2008-004064-39 |
Trial protocol |
ES |
Global end of trial date |
29 Sep 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Mar 2024
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First version publication date |
06 Mar 2024
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Other versions |
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Summary report(s) |
Sinopsis informe final CMMo/ICPD/2008 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CMMo/ICPD/2008
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Red Andaluza de Diseño y Traslación en Terapias Avanzadas (former Iniciativa Andaluza en Terapias Avanzadas) – Fundación Progreso y Salud
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Sponsor organisation address |
Avda. Américo Vespucio 15 · Edificio S-2 ·2ª Pta , Sevilla, Spain,
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Public contact |
Rosario Carmen Mata Alcázar-Caballero, Red Andaluza de Diseño y Traslación en Terapias Avanzadas (former Iniciativa Andaluza en Terapias A, +34 955 048 366, terapias.avanzadas@juntadeandalucia.es
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Scientific contact |
Rosario Carmen Mata Alcázar-Caballero, Red Andaluza de Diseño y Traslación en Terapias Avanzadas (former Iniciativa Andaluza en Terapias A, +34 955 048 366, terapias.avanzadas@juntadeandalucia.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Oct 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Sep 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Sep 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety and feasibility of autologous mononucleated bone marrow cell transplantation (mo-MNCs) administered intra-arterially in the affected limb of diabetic patients with chronic critical ischemia of the lower limbs without possibilities of revascularization or other therapeutic alternatives.
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Protection of trial subjects |
The trial has been carried out in accordance with the recommendations for Clinical Trials and the evaluation of the product under investigation in humans, which appear in the Declaration of Helsinki, revised in successive world assemblies (WMA, 2008), and the current Spanish Legislation on Clinical Trials. In addition, the ICH-GPC standards have been followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
35
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From 65 to 84 years |
25
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
Pre-assignment
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Screening details |
- | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
60 | |||||||||||||||
Number of subjects completed |
60 | |||||||||||||||
Period 1
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Period 1 title |
Safety and feasibility (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group control | |||||||||||||||
Arm description |
Conventional treatment | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Not assigned
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Routes of administration |
Not mentioned
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Dosage and administration details |
NA
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Arm title
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Group 1 | |||||||||||||||
Arm description |
Autologous bone marrow mononucleated cells | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Autologous bone marrow mononucleated cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intraarterial use
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Dosage and administration details |
1x10e8 de mo-CMNs
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Arm title
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Group 2 | |||||||||||||||
Arm description |
Autologous bone marrow mononucleated cells | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Autologous bone marrow mononucleated cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intraarterial use
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Dosage and administration details |
5x10e8 de mo-CMNs
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Arm title
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Group 3 | |||||||||||||||
Arm description |
Autologous bone marrow mononucleated cells | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Not assigned
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Routes of administration |
Not mentioned
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Dosage and administration details |
NA
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Investigational medicinal product name |
Autologous bone marrow mononucleated cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intraarterial use
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Dosage and administration details |
1x10e9 de mo-CMNs
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End points reporting groups
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Reporting group title |
Group control
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Reporting group description |
Conventional treatment | ||
Reporting group title |
Group 1
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Reporting group description |
Autologous bone marrow mononucleated cells | ||
Reporting group title |
Group 2
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Reporting group description |
Autologous bone marrow mononucleated cells | ||
Reporting group title |
Group 3
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Reporting group description |
Autologous bone marrow mononucleated cells |
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End point title |
Degree of vasculogenesis [1] | ||||||||||||||||||||
End point description |
The following data correspond to the transcutaneous oxygen pressure observed in both the control group and the treatment group 12 months after treatment.
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End point type |
Primary
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End point timeframe |
During the study
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses for this end point |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From the inclusion of the first patient to the last visit of the last patient.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: It is detailed in the summary of the final report |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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10 Mar 2009 |
Inclusion of a new collaborating service from another center |
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19 May 2009 |
Amendment not relevant |
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29 Oct 2009 |
Amendment not relevant |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |