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

NCT04533464 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: B06-01
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma; Adult Stem Cells

Outcome Measures

Primary Outcomes (1)

• A composite of the highest Acute Kidney Injury stage (based on KDIGO guidelines)

  Day 30

Secondary Outcomes (6)

• Mortality

  Day 30, Day 90, Day 365

• Incidence of Acute Kidney Injury adjusted for the competing risk of death

  Day 30

• Incidence of sepsis, Acute Respiratory Distress Syndrome, Multiple Organ Failure, and Venous Thromboembolism

  Day 30

• Hospital days

  Day 30

• ICU days

  Day 30

Study Arms (2)

MultiStem

EXPERIMENTAL

Biological: MultiStem

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

MultiStem BIOLOGICAL

Intravenous Infusion

MultiStem

Placebo BIOLOGICAL

Intravenous Infusion

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Prisoners, defined as those who have been directly admitted from a correctional facility.
• Prisoners are excluded because of their vulnerable population status. A free-living individual who is under police observation as a suspect will remain in the study until discharge or incarcerated.
• 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.
• 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.
• 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.
• Greater than 20% total body surface area burns and/or suspected inhalation injury.
• Subjects with large and severe thermal injuries and inhalation injures require a resuscitation approach that is different from current isolated trauma resuscitation strategies. Additionally, in the absence of concomitant severe blunt trauma, these subjects are unlikely to receive blood products in the early resuscitative phase.
• 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.
• 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.
• Known condition of single kidney or concurrent use of potentially nephrotoxic medications at doses likely to be nephrotoxic
• Known immunodeficient condition or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status
• Known allergy to MultiStem, dimethyl sulfoxide or human serum albumin
• 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
• Clinical condition would be anticipated to deteriorate with intravenous administration of 250 ml of crystalloid
• Known Do Not Resuscitate (DNR) prior to randomization

Sponsors & Collaborators

• Healios K.K.: lead
• Memorial Hermann Hospital: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Healios Investigational Site

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Charles Cox, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: November 9, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)