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

NCT ID: NCT04533464

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MultiStem

Group Type: EXPERIMENTAL

MultiStem

Intervention Type: BIOLOGICAL

Intravenous Infusion

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intravenous Infusion

Interventions

MultiStem

Intravenous Infusion

Intervention Type: BIOLOGICAL

Placebo

Intravenous Infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

1. 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.

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Hermann Hospital

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Healios K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Cox, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Healios Investigational Site

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charles Cox, MD

Role: CONTACT

Charles.S.Cox@uth.tmc.edu

713-500-7300

Jeanette Podbielski, RN

Role: CONTACT

Jeanette.M.Podbielski@uth.tmc.edu

713-500-6407

Facility Contacts

Jeanette Podbielski, RN

Role: primary

Jeanette.M.Podbielski@uth.tmc.edu

713-500-6407

Other Identifiers

B06-01

Identifier Type: -

Identifier Source: org_study_id