Study of ALD-401 Via Intracarotid Infusion in Ischemic Stroke Subjects

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Stroke, Ischemic Stroke, Stroke in Middle Cerebral Artery (MCA)

In brief

The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke.

Key facts

Study ID: NCT01273337
Run by: Aldagen
People needed: 100
Starts: 2011-03-01
Expected to finish: 2015-01-01
Last updated by the study team: 2014-01-16

Who can join

Age: 30 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is age 30 to 83 years,
Has recent acute ischemic stroke in the middle cerebral artery (MCA) distribution confirmed by MRI or CT scan, with known onset time (within 24 hr),
Has persistent neurological deficit (NIHSS ≤22), mRS ≥ 3 at randomization,
Is able to provide bone marrow sample from anterior or posterior iliac crest at the time required by targeted infusion date,
Is able to return for dosing two days post bone marrow harvest (day 13-19 post stroke) and remain overnight for observation,
Is able to undergo (no contraindications) catheterization for localizing arteriograms for intracarotid/MCA delivery,
Has patency of the carotid artery on the affected side demonstrated at screening and prior to infusion; and flow is established in the proximal branches (M1 and M2) of the affected carotid if the stroke is cortical. Occlusion of either the M1 or M2 can be included in the study if imaging prior to harvest demonstrates flow through collateral circulation to the area of the infarct. If the infarction is lacunar, the proximal MCA must be patent,
Subjects who received tPA or underwent mechanical reperfusion may be included in the study as long as flow is established either in the proximal branches (M1 and M2) of the affected carotid or in the collateral circulation to the area of the infarct,
Has a general state that is compatible with a program of functional rehabilitation, and is receiving standard of care as determined by the investigator,
Is able to provide consent to study or informed consent is obtained from the subject's next of kin or legal representative,
Females must be postmenopausal, surgically sterilized, or practicing a suitable method of birth control so that, in the opinion of the investigator, they will not become pregnant during the course of the study,
Is a good candidate for the trial, in the opinion of the investigator.

You may not qualify if…

Medical Conditions:
Has a medical history of neurological or orthopedic pathology with deficit as a consequence that results in a modified Rankin Scale score >1 before stroke) or has a cognitive deficit,
Has a severe, persistent neurological deficit (NIHSS >22), OR a change of ≥4 points in the NIHSS from screening (after 7 days) to randomization (3-4 days after screening),
Has any clinically significant hemorrhagic (HI1 or PH1 petechial hemorrhages are allowed), or traumatic lesion of the brain on MRI or CT,
Has stroke affecting the sub cortical area only,
Has >50% stenosis or ulcerated plaque in the carotid artery on the ipsilateral side and carotid endarterectomy or arterial stenting is recommended for treatment,
Has had a seizure in the past 6 months (including associated with stroke),
Has a serious psychiatric disease which could alter evaluation on functional or cognitive scales,
Has a serious neurologic disease (e.g., multiple sclerosis, ALS) which could alter evaluation on functional or cognitive scales,
Had a myocardial infarction in the past 3 months,
Has a mechanical heart valve,
Has a history of ischemic stroke in any distribution within one month of the date of onset of the qualifying stroke for inclusion into this study,
Has known hepatic failure (Child-Pugh score Class B or C),
Has an active systemic infection,
Has an active malignancy or diagnosis of malignancy within 5 years prior to the start of screening (excluding skin cancers other than melanoma) or any history of chemotherapy or radiation affecting the bone marrow,
Has a history of inflammatory or progressively fibrotic conditions (e.g., rheumatoid arthritis, systemic lupus erythematosis, vasculitic disorders, idiopathic pulmonary fibrosis, retroperitoneal fibrosis),
Has another comorbid disease, including cardiovascular disease, which would be expected to result in less than 6-months life expectancy,
Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety and/or efficacy,
Has current or recent history of alcohol or drug abuse, or stroke considered associated with drug abuse.
Laboratory Findings:
Hemoglobin <10 g/dl,
Uncorrected coagulopathy as defined as INR >1.4; PTT >35 sec,
Platelet counts of <100,000 or >700,000,
Any hemodynamic instability at the time of consent (e.g., requiring continuous fluid resuscitation or ionotropic support), or hypoxemia (oxygen saturation of < 90%) on supplemental oxygen more than FIO2 = 0.3,
Renal insufficiency (creatinine clearance of < 50 mL/min/m2).

Where it is running

Los Angeles Brain and Spine Institute — Los Angeles, California, United States
University of Miami Hospital — Miami, Florida, United States
Minneapolis Heart Institute — Minneapolis, Minnesota, United States
Duke University Medical Center — Durham, North Carolina, United States
Ohio Health Research Institute — Columbus, Ohio, United States
University of Pittsburgh Medical Center Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
University Medical Center at Brackenridge — Austin, Texas, United States
The University of Texas Medical School — Houston, Texas, United States
Swedish Medical Center, Cherry Hill Campus — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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