Clinical Trial Results:
A MULTICENTER PHASE I/II, OPEN, RANDOMIZED, RANDOMIZED CLINICAL TRIAL TO STUDY THE USE OF MESENCHYMAL STEM CELLS DERIVED FROM ADIPOSE TISSUE (CeTMAd) AS A CELL REGENERATION THERAPY FOR CRITICAL LOWER LIMB CRITICAL ISCHEMIA SYNDROME IN NON-DIABETIC PATIENTS.
Summary
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EudraCT number |
2009-013554-32 |
Trial protocol |
ES |
Global end of trial date |
13 Dec 2018
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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) |
Final Report_Summary |
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 |
CeTMAd/ICC/2009
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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 |
Fundación Pública Andaluza Progreso y Salud M.P.
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Sponsor organisation address |
Avda. Américo Vespucio 15 · Edificio S-2 · 2ª Pta, Sevilla, Spain, 41092
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Public contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es
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Scientific contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@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 |
23 Jan 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Dec 2018
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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 |
- Seguridad: Se estudiarán las posibles complicaciones derivadas del procedimiento en las primeras 24h de la administración de las CeTMAd, 1 mes, 3 meses, 6 meses, 9 meses y 12 meses.
- Factibilidad: Se estudiará la generación de nuevos vasos (vasculogénesis) y la potenciación de la circulación colateral (angiogénesis/ arteriogénesis).
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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 |
10 Jan 2011
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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: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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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) |
28
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From 65 to 84 years |
3
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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 |
31 | ||||||||||||
Number of subjects completed |
31 | ||||||||||||
Period 1
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Period 1 title |
Recruitment and follow-up (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 1 | ||||||||||||
Arm description |
Expanded autologous adipose tissue adult mesenchymal stem cells | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Expanded autologous adipose tissue adult mesenchymal stem cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intraarterial use
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Dosage and administration details |
0,5 x 10e6 cells/kg patient
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Arm title
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Group 2 | ||||||||||||
Arm description |
Expanded autologous adipose tissue adult mesenchymal stem cells | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Expanded autologous adipose tissue adult mesenchymal stem 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 |
1 x 10e6 cells/kg patient
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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 |
Not apply
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Expanded autologous adipose tissue adult mesenchymal stem cells | ||
Reporting group title |
Group 2
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Reporting group description |
Expanded autologous adipose tissue adult mesenchymal stem cells | ||
Reporting group title |
Group control
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Reporting group description |
Conventional treatment |
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End point title |
Evaluate the safety and feasibility of treatment [1] | ||||||||||||
End point description |
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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 clinical 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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17 Jun 2010 |
One of the exclusion criteria was narrowed better and one of the inclusion criteria was expanded among other changes. |
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11 Jan 2011 |
The main modification in the protocol of this clinical trial consists of the elimination of one of the treatment arms specified in said protocol. Specifically, it is about the removal of the 2 x 106 treatment branch cells/kg patient. Which leads to your time, to a decrease in the number of patients to recruit from 48 to 30 patients evaluable in total. |
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20 Apr 2012 |
The main modification in the protocol of this clinical trial consists of the expansion of the recruitment period. |
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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 |