Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hope Biosciences Research Foundation
Age
14–78
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male and female patients 14 - 78 years of age
2. Patient should provide evidence of TBI or non -TBI as evidenced by documentation in their medical records and imaging that was done within the past 3 years.
3. Female participants of childbearing potential should not be pregnant or plan to become pregnant during protocol participation and for 6 months after the last investigational product administration. Female participants of childbearing potential should confirm the use of one of the following contraceptive measures:
* Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
* Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
* Surgery (occlusion bilateral tubal ligation, hysterectomy, vasectomized partner).
OR
Male participants if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during protocol participation and for 6 months after the last administration of the investigated product:
* Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
* Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
* Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy (partner)).
4. Patient/LAR should be able to read, understand, and to provide voluntary consent.
You may not be if
1. Women who are currently pregnant or lactating.
2. The patient has any active infection requiring medications per PI's discretion.
3. The patient has any clinical signs or symptoms of infection per PI's discretion.
4. The patient has hyperthermia or hypothermia.
5. The patient has any known recent (within the last 6 months) coagulation anomalies that are not being medically treated and are not stable per PI's discretion.
6. The patient has any abnormal laboratory values at the screening visit which the Investigator determines to be clinically significant and make the patient unsuitable for participation.
7. The Investigator determines the patient to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.
Clareo Health | Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury
