The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)
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ClinicalTrials.gov Identifier: NCT01087996 |
Recruitment Status :
Completed
First Posted : March 16, 2010
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Stem Cell Transplantation |
Interventions |
Biological: Auto-hMSCs Biological: Allo-hMSCs |
Enrollment | 31 |
Recruitment Details | Participants were enrolled between April 2, 2010 and September 14, 2011 |
Pre-assignment Details | One patient did not receive Autologous MSCs because they became ineligible. |
Arm/Group Title | Allo-hMSCs | Auto-hMSCs |
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Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
Period Title: Overall Study | ||
Started | 15 | 15 |
Completed | 15 | 15 |
Not Completed | 0 | 0 |
Arm/Group Title | Allo-hMSCs | Auto-hMSCs | Total | |
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Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells. Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells. Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 15 | 15 | 30 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 15 participants | 30 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
9 60.0%
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5 33.3%
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14 46.7%
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>=65 years |
6 40.0%
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10 66.7%
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16 53.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 15 participants | 15 participants | 30 participants | |
62.8 (10.5) | 63.7 (9.3) | 63.2 (9.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 15 participants | 30 participants | |
Female |
2 13.3%
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2 13.3%
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4 13.3%
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Male |
13 86.7%
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13 86.7%
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26 86.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 15 participants | 15 participants | 30 participants |
15 | 15 | 30 |
Name/Title: | Adam Mendizabal |
Organization: | The EMMES Corporation |
Phone: | 301 251 1161 ext 221 |
EMail: | amendizabal@emmes.com |
Responsible Party: | Joshua M Hare, University of Miami |
ClinicalTrials.gov Identifier: | NCT01087996 |
Other Study ID Numbers: |
20090352 R01HL110737 ( U.S. NIH Grant/Contract ) R01HL107110 ( U.S. NIH Grant/Contract ) R01HL084275 ( U.S. NIH Grant/Contract ) P20HL101443 ( U.S. NIH Grant/Contract ) R01HL094849 ( U.S. NIH Grant/Contract ) |
First Submitted: | March 15, 2010 |
First Posted: | March 16, 2010 |
Results First Submitted: | August 30, 2013 |
Results First Posted: | May 27, 2015 |
Last Update Posted: | May 27, 2015 |