RECRUITING

MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.

Official Title

MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome

Quick Facts

Study Start:2020-11-09

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04533464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years of age or older AND 2. Received at least 3 units of any blood product in any hour before Shock Trauma Intensive Care Unit (STICU) arrival AND 3. Survived to initial ICU arrival AND 4. Initial hemostasis has been achieved, in the opinion of the attending surgeon AND 5. Predicted to survive at least 24 hours after STICU arrival by the attending physician AND 6. Ability to start and complete investigational product infusion within 24 hours after known or estimated time of injury.	1. Prisoners, defined as those who have been directly admitted from a correctional facility. 2. Pregnant and lactating females. It is unknown how stem cells affect a developing fetus or if they can be found in milk. To protect the safety of developing fetuses and breastfeeding children, pregnant and lactating women will be excluded. 3. Have a head injury deemed non-survivable by the trauma or neurosurgery attending. The attending physician may determine futility from a range of injuries/physiological responses. These may include non-survivable TBI (malignant ICP elevation despite maximal therapy with findings of uncal herniation and/or brain dead exam; atlantooccipital dissociation), cardio-pulmonary failure refractory to resuscitation and those patients with an advanced directive that declines resuscitative or organ support therapies. 4. Hemodynamically unstable or requiring clinically meaningful escalation of vasopressor dose for blood pressure support (to maintain SBP ≥ 90 mmHg) during the 30 minute period prior to study product thawing/preparation. Clinically meaningful vasopressor dose adjustment defined as ≥ 5 mcg/min increase in norepinephrine dose; ≥ 50 mcg/min increase in phenylephrine dose; ≥ 5 mcg/kg/min increase in dopamine dose; and ≥ 0.05 mcg/kg/min increase in epinephrine dose. If the patient is on vasopressin, investigators will be instructed not to titrate the vasopressin dose during this 30 minute period. 5. Greater than 20% total body surface area burns and/or suspected inhalation injury. 6. Preexisting chronic kidney disease, defined by prior documented glomerular filtration rate less than 60 mL/min/1.73m2 for 3 months or more. Patients who are unable to communicate their pre-existing conditions will be excluded by Medical Alert bracelets/IDs, stigmata pathognomonic for chronic kidney disease such as presence of dialysis vascular access devices or shunts/markedly elevated BUN/Creatinine, or abdominal incisions consistent with organ transplantation, etc. 7. Preexisting chronic liver disease, evidenced by clinical or laboratory examinations consistent with chronic liver disease/failure (Childs A-C), patient or family report, Medical Alert bracelets/IDs or abdominal incisions consistent with organ transplantation, etc. 8. Known condition of single kidney or concurrent use of potentially nephrotoxic medications at doses likely to be nephrotoxic 9. Known immunodeficient condition or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status 10. Known allergy to MultiStem, dimethyl sulfoxide or human serum albumin 11. No available intravenous access (peripheral or central) of at least 22-guage that can be utilized exclusively for investigational product during the time of planned infusion 12. Clinical condition would be anticipated to deteriorate with intravenous administration of 250 ml of crystalloid 13. Known Do Not Resuscitate (DNR) prior to randomization 14. Enrolled in a concurrent ongoing interventional clinical trial 15. Known functional asplenia or prior surgical removal of the spleen, or a trauma related splenic injury sufficient to precluding enrollment as determined by the PI or Co- Investigators. (trauma related splenic injuries include surgical total splenectomy or nonoperative management of AAST grade V splenic injury including splenic arterial embolization.\* \*Proximal splenic arterial embolization to control bleeding that leaves the spleen in situ and perfused (below Grade V) does not necessarily exclude the patient. Further, achieving Grade V, with an upgraded score due to a secondary small laceration, etc. away from primary injury will be considered a Grade IV for the purposes of the protocol.

Inclusion Criteria

Exclusion Criteria

1. 18 years of age or older AND
2. Received at least 3 units of any blood product in any hour before Shock Trauma Intensive Care Unit (STICU) arrival AND
3. Survived to initial ICU arrival AND
4. Initial hemostasis has been achieved, in the opinion of the attending surgeon AND
5. Predicted to survive at least 24 hours after STICU arrival by the attending physician AND
6. Ability to start and complete investigational product infusion within 24 hours after known or estimated time of injury.

1. Prisoners, defined as those who have been directly admitted from a correctional facility.
2. Pregnant and lactating females. It is unknown how stem cells affect a developing fetus or if they can be found in milk. To protect the safety of developing fetuses and breastfeeding children, pregnant and lactating women will be excluded.
3. Have a head injury deemed non-survivable by the trauma or neurosurgery attending. The attending physician may determine futility from a range of injuries/physiological responses. These may include non-survivable TBI (malignant ICP elevation despite maximal therapy with findings of uncal herniation and/or brain dead exam; atlantooccipital dissociation), cardio-pulmonary failure refractory to resuscitation and those patients with an advanced directive that declines resuscitative or organ support therapies.
4. Hemodynamically unstable or requiring clinically meaningful escalation of vasopressor dose for blood pressure support (to maintain SBP ≥ 90 mmHg) during the 30 minute period prior to study product thawing/preparation. Clinically meaningful vasopressor dose adjustment defined as ≥ 5 mcg/min increase in norepinephrine dose; ≥ 50 mcg/min increase in phenylephrine dose; ≥ 5 mcg/kg/min increase in dopamine dose; and ≥ 0.05 mcg/kg/min increase in epinephrine dose. If the patient is on vasopressin, investigators will be instructed not to titrate the vasopressin dose during this 30 minute period.
5. Greater than 20% total body surface area burns and/or suspected inhalation injury.
6. Preexisting chronic kidney disease, defined by prior documented glomerular filtration rate less than 60 mL/min/1.73m2 for 3 months or more. Patients who are unable to communicate their pre-existing conditions will be excluded by Medical Alert bracelets/IDs, stigmata pathognomonic for chronic kidney disease such as presence of dialysis vascular access devices or shunts/markedly elevated BUN/Creatinine, or abdominal incisions consistent with organ transplantation, etc.
7. Preexisting chronic liver disease, evidenced by clinical or laboratory examinations consistent with chronic liver disease/failure (Childs A-C), patient or family report, Medical Alert bracelets/IDs or abdominal incisions consistent with organ transplantation, etc.
8. Known condition of single kidney or concurrent use of potentially nephrotoxic medications at doses likely to be nephrotoxic
9. Known immunodeficient condition or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status
10. Known allergy to MultiStem, dimethyl sulfoxide or human serum albumin
11. No available intravenous access (peripheral or central) of at least 22-guage that can be utilized exclusively for investigational product during the time of planned infusion
12. Clinical condition would be anticipated to deteriorate with intravenous administration of 250 ml of crystalloid
13. Known Do Not Resuscitate (DNR) prior to randomization
14. Enrolled in a concurrent ongoing interventional clinical trial
15. Known functional asplenia or prior surgical removal of the spleen, or a trauma related splenic injury sufficient to precluding enrollment as determined by the PI or Co- Investigators. (trauma related splenic injuries include surgical total splenectomy or nonoperative management of AAST grade V splenic injury including splenic arterial embolization.\* \*Proximal splenic arterial embolization to control bleeding that leaves the spleen in situ and perfused (below Grade V) does not necessarily exclude the patient. Further, achieving Grade V, with an upgraded score due to a secondary small laceration, etc. away from primary injury will be considered a Grade IV for the purposes of the protocol.

Contacts and Locations

Study Contact

Charles Cox, MD

CONTACT

713-500-7300

Charles.S.Cox@uth.tmc.edu

Jeanette Podbielski, RN

CONTACT

713-500-6407

Jeanette.M.Podbielski@uth.tmc.edu

Principal Investigator

Charles Cox, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

Healios Investigational Site

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Healios K.K.

Charles Cox, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-09

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-11-09

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Trauma
Adult Stem Cells