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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859014
• Other study ID #: N01-HB-37163-05
• Secondary ID: R21HD060978
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2009
• Last updated: December 31, 2014
• Start date: January 2009
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 83 Years

Eligibility

Inclusion Criteria:

1. acute ischemic stroke

2. age 18 to 83 years If >80 then the pre-stroke mRS needs to be < 1)

3. Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18

4. known onset time of acute symptoms

5. stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset

6. TPA infusion is allowed

Exclusion Criteria:

1. NIHSS 1a > 1

2. pre-stroke mRS > 1 if > 80 years of age

3. Ischemic stroke in the last 3 months, any vascular territory

4. 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.

5. seizure disorder

6. developmental delay

7. chronic kidney disease defined as baseline creatinine >1.4

8. hepatic disease or altered liver function as defined by SGPT >150 U/L and or T. Bilirubin >1.6 mg/dL at admission

9. pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)

10. mechanical heart valve

11. 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.

12. prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC <3 x 103 cells/ml

13. known HIV

14. hemoglobin <10g/dl

15. uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>37 sec, or thrombocytopenia (PLT<100,000)

16. any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support).

17. Hypoxemia (SaO2<90%) at the time of consent, respiratory distress or persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent. Intubation alone is not an exclusion.

18. pregnancy or positive b-HCG

19. current participation in any interventional research study

20. unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation

21. Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)

22. Unable to undergo MRI or CT scan

23. Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.

24. Exclude infarct lesion size >145cc unless the NIHSS 1a remains < 1 and there is no evidence of infarct expansion or edema formation on any imaging obtained from admission up to the point just prior to infusion.

25. Exclude IA therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed

26. CT and/or Multimodal MRI exclusion criteria will be:

• hemispheric strokes < 1.5 cm maximum diameter (on the MRI as seen on the diffusion-weighted imaging or CT)

• midline shift >1mm or significant hemorrhagic transformation of the acute infarct

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Biological:
• Autologous Bone Marrow Mononuclear Cells
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

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital-Medical Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Related Serious Adverse Events (SR-SAE)	Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"	2 Years	Yes
Secondary	Functional Outcome	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.	90-days	No