Trial Outcomes & Findings for Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients (NCT NCT00859014)
NCT ID: NCT00859014
Last Updated: 2015-01-01
Results Overview
Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
2 Years
Results posted on
2015-01-01
Participant Flow
Participant milestones
| Measure |
Autologous Bone Marrow Mononuclear Cells
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 Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Autologous Bone Marrow Mononuclear Cells
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 Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
Baseline characteristics by cohort
| Measure |
Autologous Bone Marrow Mononuclear Cells
n=25 Participants
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.
|
|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 YearsStudy Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
Outcome measures
| Measure |
Autologous Bone Marrow Mononuclear Cells
n=25 Participants
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.
|
|---|---|
|
Study Related Serious Adverse Events (SR-SAE)
|
0 Events
|
SECONDARY outcome
Timeframe: 90-daysModified 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.
Outcome measures
| Measure |
Autologous Bone Marrow Mononuclear Cells
n=25 Participants
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.
|
|---|---|
|
Functional Outcome
|
3 units on a scale
Interval 2.0 to 3.0
|
Adverse Events
Autologous Bone Marrow Mononuclear Cells
Serious events: 15 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Autologous Bone Marrow Mononuclear Cells
n=25 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Ischemic Stroke
|
8.0%
2/25 • 2 Years
|
|
Cardiac disorders
Myocardial Infarction
|
4.0%
1/25 • 2 Years
|
|
Nervous system disorders
Stroke Expansion
|
12.0%
3/25 • 2 Years
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • 2 Years
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • 2 Years
|
|
Renal and urinary disorders
Renal Failure
|
12.0%
3/25 • 2 Years
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
4.0%
1/25 • 2 Years
|
|
Nervous system disorders
Seizure
|
8.0%
2/25 • 2 Years
|
|
Nervous system disorders
Carotid Hyperperfusion Syndrome
|
4.0%
1/25 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary Non Small Cell Lung Carcinoma
|
4.0%
1/25 • 2 Years
|
|
Cardiac disorders
Congestive Heart Failure
|
4.0%
1/25 • 2 Years
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.0%
1/25 • 2 Years
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Fracture Lumbar Vertebra
|
4.0%
1/25 • 2 Years
|
|
General disorders
Numbness
|
4.0%
1/25 • 2 Years
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • 2 Years
|
|
Renal and urinary disorders
Pyelonephritis
|
4.0%
1/25 • 2 Years
|
|
General disorders
Hospital admission for observation
|
4.0%
1/25 • 2 Years
|
Other adverse events
| Measure |
Autologous Bone Marrow Mononuclear Cells
n=25 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
5/25 • 2 Years
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
12.0%
3/25 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
36.0%
9/25 • 2 Years
|
|
Gastrointestinal disorders
Colitis
|
8.0%
2/25 • 2 Years
|
|
General disorders
Nausea
|
8.0%
2/25 • 2 Years
|
|
General disorders
Vomitting
|
8.0%
2/25 • 2 Years
|
|
General disorders
Culture Bottle Skin Contamination, Suspected
|
20.0%
5/25 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.0%
3/25 • 2 Years
|
|
Infections and infestations
Urinary Tract Infection
|
40.0%
10/25 • 2 Years
|
|
General disorders
Fall
|
8.0%
2/25 • 2 Years
|
|
Blood and lymphatic system disorders
Prolonged Partial Thromboplastin Time
|
12.0%
3/25 • 2 Years
|
|
Investigations
Increased Alanine Aminotransferase
|
28.0%
7/25 • 2 Years
|
|
Investigations
Increased Aspartate Aminotransferase
|
44.0%
11/25 • 2 Years
|
|
Investigations
Increased INR
|
20.0%
5/25 • 2 Years
|
|
Investigations
Increased Lipase
|
8.0%
2/25 • 2 Years
|
|
Investigations
Hyperglycemia
|
24.0%
6/25 • 2 Years
|
|
Investigations
Hypernatremia
|
12.0%
3/25 • 2 Years
|
|
Investigations
Hypoalbuminemia
|
16.0%
4/25 • 2 Years
|
|
Investigations
Hypocalcemia
|
28.0%
7/25 • 2 Years
|
|
Investigations
Hypokalemia
|
12.0%
3/25 • 2 Years
|
|
Investigations
Hyponatremia
|
16.0%
4/25 • 2 Years
|
|
Investigations
Hypophosphatemia
|
12.0%
3/25 • 2 Years
|
|
General disorders
Headache
|
8.0%
2/25 • 2 Years
|
|
Nervous system disorders
Hemorrhagic Transformation of Ischemic Stroke
|
28.0%
7/25 • 2 Years
|
|
Nervous system disorders
Ischemic Stroke
|
8.0%
2/25 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
20.0%
5/25 • 2 Years
|
|
General disorders
Decubitus Ulcer
|
12.0%
3/25 • 2 Years
|
|
General disorders
Peripheral Edema
|
12.0%
3/25 • 2 Years
|
|
Vascular disorders
Hypotension
|
20.0%
5/25 • 2 Years
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
56.0%
14/25 • 2 Years
|
Additional Information
Dr. Sean I. Savitz, Professor and Director of Stroke
University of Texas Health Science Center
Phone: 713.500.7083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place