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Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00859014
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Intervention Biological: Autologous Bone Marrow Mononuclear Cells
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous Bone Marrow Mononuclear Cells
Hide Arm/Group Description Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Period Title: Overall Study
Started 25
Completed 20
Not Completed 5
Reason Not Completed
Death             4
Lost to Follow-up             1
Arm/Group Title Autologous Bone Marrow Mononuclear Cells
Hide Arm/Group Description Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Total number of study participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
60.7  (13.3)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  52.0%
>=65 years
12
  48.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Study Related Serious Adverse Events (SR-SAE)
Hide Description Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Bone Marrow Mononuclear Cells
Hide Arm/Group Description:
Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Events
0
2.Secondary Outcome
Title Functional Outcome
Hide Description Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.
Time Frame 90-days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Bone Marrow Mononuclear Cells
Hide Arm/Group Description:
Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Overall Number of Participants Analyzed 25
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(2 to 3)
Time Frame 2 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous Bone Marrow Mononuclear Cells
Hide Arm/Group Description Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
All-Cause Mortality
Autologous Bone Marrow Mononuclear Cells
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autologous Bone Marrow Mononuclear Cells
Affected / at Risk (%)
Total   15/25 (60.00%) 
Cardiac disorders   
Myocardial Infarction * [1]  1/25 (4.00%) 
Congestive Heart Failure * [1]  1/25 (4.00%) 
Bradycardia * [1]  1/25 (4.00%) 
General disorders   
Numbness * [1]  1/25 (4.00%) 
Hospital admission for observation * [1]  1/25 (4.00%) 
Infections and infestations   
Sepsis * [1]  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Fracture Lumbar Vertebra * [1]  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Primary Non Small Cell Lung Carcinoma * [1]  1/25 (4.00%) 
Nervous system disorders   
Ischemic Stroke * [1]  2/25 (8.00%) 
Stroke Expansion * [1]  3/25 (12.00%) 
Syncope * [1]  2/25 (8.00%) 
Seizure * [1]  2/25 (8.00%) 
Carotid Hyperperfusion Syndrome * [1]  1/25 (4.00%) 
Renal and urinary disorders   
Renal Failure * [1]  3/25 (12.00%) 
Urinary Tract Infection * [1]  1/25 (4.00%) 
Pyelonephritis * [1]  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Edema * [1]  1/25 (4.00%) 
Vascular disorders   
Hypotension * [1]  1/25 (4.00%) 
Hypertension * [1]  1/25 (4.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Not Study Related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Autologous Bone Marrow Mononuclear Cells
Affected / at Risk (%)
Total   24/25 (96.00%) 
Blood and lymphatic system disorders   
Anemia * [1]  5/25 (20.00%) 
Leukocytopenia * [1]  3/25 (12.00%) 
Prolonged Partial Thromboplastin Time * [1]  3/25 (12.00%) 
Decreased Hemoglobin * [2]  14/25 (56.00%) 
Gastrointestinal disorders   
Colitis * [1]  2/25 (8.00%) 
General disorders   
Nausea * [1]  2/25 (8.00%) 
Vomitting *  2/25 (8.00%) 
Culture Bottle Skin Contamination, Suspected *  5/25 (20.00%) 
Fall * [1]  2/25 (8.00%) 
Headache * [1]  2/25 (8.00%) 
Decubitus Ulcer * [1]  3/25 (12.00%) 
Peripheral Edema * [1]  3/25 (12.00%) 
Infections and infestations   
Urinary Tract Infection * [3]  10/25 (40.00%) 
Investigations   
Increased Alanine Aminotransferase * [4]  7/25 (28.00%) 
Increased Aspartate Aminotransferase * [5]  11/25 (44.00%) 
Increased INR * [1]  5/25 (20.00%) 
Increased Lipase * [6]  2/25 (8.00%) 
Hyperglycemia * [1]  6/25 (24.00%) 
Hypernatremia * [1]  3/25 (12.00%) 
Hypoalbuminemia * [1]  4/25 (16.00%) 
Hypocalcemia * [1]  7/25 (28.00%) 
Hypokalemia * [1]  3/25 (12.00%) 
Hyponatremia * [1]  4/25 (16.00%) 
Hypophosphatemia * [1]  3/25 (12.00%) 
Musculoskeletal and connective tissue disorders   
Pain * [7]  9/25 (36.00%) 
Nervous system disorders   
Hemorrhagic Transformation of Ischemic Stroke * [8]  7/25 (28.00%) 
Ischemic Stroke * [9]  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia * [10]  3/25 (12.00%) 
Atelectasis * [1]  5/25 (20.00%) 
Vascular disorders   
Hypotension * [11]  5/25 (20.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Not Study Related
[2]
Six Not Study Related. All events grade 1 and 2
[3]
Nine patients were foley catheter associated. Remaining (one) experienced symptoms prior to infusion
[4]
All events are grade 1. All patients were on statins. Three patients had transient increase within 30 days and resolved. Three patients continued to fluctuate beyond 30 days. Two patients had normal ALT up till 30 days and later had elevation
[5]
All events are grade 1. All patients were on statins. Five patients had transient increase within 30 days and resolved. Two patients continued to fluctuate beyond 30 days. Four patients had normal AST up till 30 days and later had elevation
[6]
Adjudicated as statin related
[7]
Non-specific Musculoskeletal Pain
[8]
All events are grade 1 and were asymptomatic.
[9]
All events are grade 1, were asymptomatic, and were not study related.
[10]
Not Study Related. All occurred greater than 4 months after enrollment
[11]
Four events were not study related. Remaining (one) was relative hypotension.
This is a Phase I safety and feasibility study, designed without a control group. Small sample size and inclusion of selected patients warrants caution in interpretation of findings. A randomized controlled study is needed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sean I. Savitz, Professor and Director of Stroke
Organization: University of Texas Health Science Center
Phone: 713.500.7083
EMail: sean.i.savitz@uth.tmc.edu
Layout table for additonal information
Responsible Party: Sean Savitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00859014     History of Changes
Other Study ID Numbers: N01-HB-37163-05
R21HD060978 ( U.S. NIH Grant/Contract )
First Submitted: March 9, 2009
First Posted: March 10, 2009
Results First Submitted: December 18, 2014
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015