This expanded access protocol is part of IND 031942 to evaluate efficacy and safety ofmultiple intravenous administrations of autologous HB-adMSCs for the treatment ofnontraumatic or traumatic brain injury for up to 7 patients who passed pre-screening,completed screening, and were not randomized into the treatment group for the HBBI01clinical study protocol entitled, "An Intermediate Size Patient Population ExpandedAccess Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for theTreatment of Patients with Traumatic or Nontraumatic Brain Injury." under IND 027396.
Not Provided
Biological: HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
Participants will receive allogenic HB-adMSCs through intravenous infusion only, with a
treatment duration of 16 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium
chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a
dosing regimen of approximately 2 weeks between infusion 1, infusion 2 and infusion 3,
and 4 weeks between the remaining infusions.
Inclusion Criteria:
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).
- Barrier contraceptive methods (condoms, diaphragm, etc.).
- 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).
- Barrier contraceptive methods (condoms, diaphragm, etc.).
- Surgery (vasectomy, occlusion bilateral tubal ligation (partner), hysterectomy
(partner)).
4. Patient/LAR should be able to read, understand, and to provide voluntary consent.
Exclusion Criteria:
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.
Hope Biosciences Research Foundation
Houston 4699066, Texas 4736286, United States
David Gonzalez, RN
346-900-0340
david@hopebio.org
Not Provided