NCT03004976 (CoBIS 2) is a Phase 2 clinical trial of Umbilical Cord Blood in Stroke, sponsored by Joanne Kurtzberg, MD.

Who is sponsoring NCT03004976?

NCT03004976 is sponsored by Joanne Kurtzberg, MD.

What drugs are being tested in NCT03004976?

Interventions in NCT03004976: Umbilical Cord Blood, Placebo.

What condition does NCT03004976 study?

NCT03004976 studies Stroke, Stroke, Acute, Brain Injury, Acute.

Is NCT03004976 still recruiting?

NCT03004976 is currently completed. Last updated 6 December 2022.

Are results published for NCT03004976?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-12-06 · How we verify

NCT03004976: CoBIS 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke

Completed Phase 2 Results posted Last updated 6 December 2022

What this trial tests

Phase 2 trial testing Umbilical Cord Blood in Stroke in 79 participants. Completed in 27 March 2021.

Timeline

14 March 2017

Primary endpoint
17 July 2020

27 March 2021

Quick facts

Lead sponsor	Joanne Kurtzberg, MD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	79
Start date	14 March 2017
Primary completion	17 July 2020
Estimated completion	27 March 2021
Sites	6 locations across United States

Drugs / interventions tested

Umbilical Cord Blood — full drug profile →
Placebo

Conditions studied

Stroke — all drugs for Stroke →
Stroke, Acute — all drugs for Stroke, Acute →
Brain Injury, Acute — all drugs for Brain Injury, Acute →

Sponsor

Joanne Kurtzberg, MD — full company profile →

Who can join

Adults 18 to 90, any sex, with Stroke or Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Shift in Modified Rankin Scale (mRS) Primary · baseline to 3 months post infusion

The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.

Group	Value	95% CI
Umbilical Cord Blood	1	0 – 2
Placebo	1	0 – 2

Number of Infusion Reactions Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	13
Placebo	4

Number of Product-related Infections Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	0
Placebo	0

Number of Alloimmunization Events Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	0
Placebo	0

Number of Graft vs. Host Disease Events Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	0
Placebo	0

Number of Study Related and Unexpected Adverse Events (AEs) Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	0
Placebo	0

Mortality Secondary · up to 1 year post infusion

Group	Value	95% CI
Umbilical Cord Blood	4
Placebo	1

Number of Participants With Functional Independence Secondary · 90 days post infusion

Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.

Group	Value	95% CI
Umbilical Cord Blood	15
Placebo	6

Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion Secondary · baseline to 30 days post infusion

Group	Value	95% CI
Umbilical Cord Blood	1	0 – 1
Placebo	1	0 – 1

Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion Secondary · baseline to 180 days post infusion

Group	Value	95% CI
Umbilical Cord Blood	1	1 – 2
Placebo	1	1 – 2

The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Secondary · 90 days post infusion

The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.

Group	Value	95% CI
Umbilical Cord Blood	6	3 – 9
Placebo	6	3 – 10

Barthel Index (BI) Score at 90 Days Secondary · 90 days post infusion

The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.

Group	Value	95% CI
Umbilical Cord Blood	80	50 – 100
Placebo	85	45 – 97.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Umbilical Cord Blood

Serious: 14/52 (27%)

Deaths: 4/52

Placebo

Serious: 11/27 (41%)

Deaths: 1/27

Serious adverse events (30 terms)

Reaction	System	Umbilical Cord Blood	Placebo
DEATH NOS	General disorders	—	—
FALL	Injury, poisoning and procedural complications	—	—
HYPERTENSION	Vascular disorders	—	—
ISCHEMIA CEREBROVASCULAR	Nervous system disorders	—	—
SEIZURE	Nervous system disorders	—	—
STROKE	Nervous system disorders	—	—
THROMBOEMBOLIC EVENT	Vascular disorders	—	—
HEART FAILURE	Cardiac disorders	—	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—	—
BRONCHIAL INFECTION	Infections and infestations	—	—
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	—	—
BULLOUS DERMATITIS	Skin and subcutaneous tissue disorders	—	—
CARDIAC ARREST	Cardiac disorders	—	—
COGNITIVE DISTURBANCE	Nervous system disorders	—	—
COLITIS	Gastrointestinal disorders	—	—
CONFUSION	Psychiatric disorders	—	—
DEHYDRATION	Metabolism and nutrition disorders	—	—
DYSPNEA	Respiratory, thoracic and mediastinal disorders	—	—
ENDOCARDITIS INFECTIVE	Infections and infestations	—	—
FRACTURE	Injury, poisoning and procedural complications	—	—
GENERALIZED MUSCLE WEAKNESS	Musculoskeletal and connective tissue disorders	—	—
HEADACHE	Nervous system disorders	—	—
HYPOTENSION	Vascular disorders	—	—
HYPOXIA	Respiratory, thoracic and mediastinal disorders	—	—
INTRACRANIAL HEMORRHAGE	Nervous system disorders	—	—

Other adverse events (96 terms — click to expand)

Reaction	System	Umbilical Cord Blood	Placebo
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	—	—
LEUKOCYTOSIS	Blood and lymphatic system disorders	—	—
EDEMA LIMBS	General disorders	—	—
FALL	Injury, poisoning and procedural complications	—	—
HYPERTENSION	Vascular disorders	—	—
COGNITIVE DISTURBANCE	Nervous system disorders	—	—
DEPRESSION	Psychiatric disorders	—	—
HEADACHE	Nervous system disorders	—	—
HYPOKALEMIA	Metabolism and nutrition disorders	—	—
HYPOTENSION	Vascular disorders	—	—
SPASTICITY	Nervous system disorders	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—
ANEMIA	Blood and lymphatic system disorders	—	—
CONSTIPATION	Gastrointestinal disorders	—	—
DIARRHEA	Gastrointestinal disorders	—	—
INSOMNIA	Psychiatric disorders	—	—
LUNG INFECTION	Infections and infestations	—	—
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIF	Metabolism and nutrition disorders	—	—
NAUSEA	Gastrointestinal disorders	—	—
THROMBOEMBOLIC EVENT	Vascular disorders	—	—
ANOREXIA	Metabolism and nutrition disorders	—	—
DEHYDRATION	Metabolism and nutrition disorders	—	—
HEMATURIA	Renal and urinary disorders	—	—
HYPERGLYCEMIA	Metabolism and nutrition disorders	—	—
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	—	—
SEIZURE	Nervous system disorders	—	—
VOMITING	Gastrointestinal disorders	—	—
ACUTE KIDNEY INJURY	Renal and urinary disorders	—	—
CARDIAC TROPONIN T INCREASED	Investigations	—	—
DYSPNEA	Respiratory, thoracic and mediastinal disorders	—	—
DYSURIA	Renal and urinary disorders	—	—
FATIGUE	General disorders	—	—
FEVER	General disorders	—	—
HYPERNATREMIA	Metabolism and nutrition disorders	—	—
HYPONATREMIA	Metabolism and nutrition disorders	—	—
ISCHEMIA CEREBROVASCULAR	Nervous system disorders	—	—
PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	—	—
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	—	—
SKIN ULCERATION	Skin and subcutaneous tissue disorders	—	—
URINARY RETENTION	Renal and urinary disorders	—	—

Most-reported serious reactions: DEATH NOS, FALL, HYPERTENSION, ISCHEMIA CEREBROVASCULAR, SEIZURE, STROKE, THROMBOEMBOLIC EVENT, HEART FAILURE.

Data from ClinicalTrials.gov NCT03004976 adverse events section.

Sponsor's own description

The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Neuroprotective Strategies for Ischemic Stroke-Future Perspectives.
Haupt M, Gerner ST, Bähr M, Doeppner TR. · · 2023 · cited 112× · PMID 36901765 · DOI 10.3390/ijms24054334
Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.
Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, et al · · 2018 · cited 82× · PMID 29752869 · DOI 10.1002/sctm.18-0008
Umbilical Cord Blood Transplants: Current Status and Evolving Therapies.
Gupta AO, Wagner JE. · · 2020 · cited 56× · PMID 33123504 · DOI 10.3389/fped.2020.570282
Cell-Based and Exosome Therapy in Diabetic Stroke.
Venkat P, Chopp M, Chen J. · · 2018 · cited 47× · PMID 29498242 · DOI 10.1002/sctm.18-0014
Stem cell transplantation for ischemic stroke.
Boncoraglio GB, Ranieri M, Bersano A, Parati EA, et al · · 2019 · cited 45× · PMID 31055832 · DOI 10.1002/14651858.cd007231.pub3
Cell-Based Therapies for Stroke: Are We There Yet?
Krause M, Phan TG, Ma H, Sobey CG, et al · · 2019 · cited 37× · PMID 31293500 · DOI 10.3389/fneur.2019.00656
Umbilical Cord Blood Transplantation: Challenges and Future Directions.
Ballen K. · · 2017 · cited 33× · PMID 28456009 · DOI 10.1002/sctm.17-0069
Neural Repair in Stroke.
Toman NG, Grande AW, Low WC. · · 2019 · cited 31× · PMID 31353939 · DOI 10.1177/0963689719863784

Verify or expand the search:

Other trials of Umbilical Cord Blood

Trials testing the same drug.

NCT04420494 — Umbilical Cord Blood Treatment for Refractory Immune Cytopenia · NA · unknown
NCT00604201 — Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic Synd · Phase 2 · completed

Other recruiting trials for Stroke

Currently open trials in the same condition.

NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
NCT07356011 — Exoskeleton for Balance · NA · recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting

Other Joanne Kurtzberg, MD trials

Trials by the same sponsor.

NCT04484077 — hCT-MSC Infusion in Adults With Autism Spectrum Disorder · Phase 1 · completed
NCT04549285 — Infusions of Mesenchymal Stromal Cells in Children With Multisystem Inflammatory Syndrome · Phase 1 · withdrawn
NCT04943289 — Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis · Phase 1 · completed
NCT04089579 — hCT-MSC in Children With Autism Spectrum Disorder · Phase 2 · completed
NCT04399889 — hCT-MSCs for COVID19 ARDS · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03004976 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Joanne Kurtzberg, MD
Last refreshed: 6 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03004976.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing