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

NCT00859014 | Completed Phase 1 Results DMC

• 2 other identifiers: N01-HB-37163-05R21HD060978
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out if bone marrow treatment (bone marrow aspiration and infusion of stem cells) can be safely used in adults who have recently (within 24-72 hours)suffered an acute ischemic stroke.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Study Related Serious Adverse Events (SR-SAE)

  Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"

  2 Years

Secondary Outcomes (1)

• Functional Outcome

  90-days

Study Arms (1)

Autologous Bone Marrow Mononuclear Cells

EXPERIMENTAL

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.

Biological: Autologous Bone Marrow Mononuclear Cells

Interventions

Autologous Bone Marrow Mononuclear Cells BIOLOGICAL

Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells

Autologous Bone Marrow Mononuclear Cells

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute ischemic stroke
• age 18 to 83 years If \>80 then the pre-stroke mRS needs to be \< 1)
• Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18
• known onset time of acute symptoms
• stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset
• TPA infusion is allowed

You may not qualify if:

• NIHSS 1a \> 1
• pre-stroke mRS \> 1 if \> 80 years of age
• Ischemic stroke in the last 3 months, any vascular territory
• MI, primary hemorrhagic or traumatic lesion of the brain within the last 3 months or identified on MRI. Small hemorrhagic transformation of the acute infarct is allowed.
• seizure disorder
• developmental delay
• chronic kidney disease defined as baseline creatinine \>1.4
• hepatic disease or altered liver function as defined by SGPT \>150 U/L and or T. Bilirubin \>1.6 mg/dL at admission
• pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)
• mechanical heart valve
• Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening or any history of chemotherapy or radiation affecting the bone marrow. Skin cancers (except for melanoma) are permitted.
• prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC \<3 x 103 cells/ml
• known HIV
• hemoglobin \<10g/dl
• uncorrected coagulopathy at the time of consent defined as INR \>1.4; PTT\>37 sec, or thrombocytopenia (PLT\<100,000)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Memorial Hermann Hospital-Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Vahidy FS, Alderman S, Savitz SI. Challenges enrolling patients with acute ischemic stroke into cell therapy trials. Stem Cells Dev. 2013 Jan 1;22(1):27-30. doi: 10.1089/scd.2012.0404. Epub 2012 Oct 15.

  PMID: 22970907 BACKGROUND

• Savitz SI, Misra V, Kasam M, Juneja H, Cox CS Jr, Alderman S, Aisiku I, Kar S, Gee A, Grotta JC. Intravenous autologous bone marrow mononuclear cells for ischemic stroke. Ann Neurol. 2011 Jul;70(1):59-69. doi: 10.1002/ana.22458.

  PMID: 21786299 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Sean I. Savitz, Professor and Director of Stroke
• Organization: University of Texas Health Science Center

sean.i.savitz@uth.tmc.edu

713.500.7083

Study Officials

• Sean I Savitz, MD

  University of Texas Heath Science Center- Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurology

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 1, 2015
• Results First Posted: January 1, 2015

Record last verified: 2014-12

Locations

US (1)