Brain InjuryNCT07164482
Intermediate Size Patient Population Expanded Access Protocol to Evaluate HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury
A study testing HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) in people with Brain Injury, run by Hope Biosciences Research Foundation at 1 site in United States.
Trial summary
This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment… Read more about this study
- Who is it for?
- Ages 14 to 78 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 78 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Male and female patients 14 - 78 years of age
- 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.
- 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.).
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- 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)).
- Patient/LAR should be able to read, understand, and to provide voluntary consent.
Who cannot join
- Women who are currently pregnant or lactating.
- The patient has any active infection requiring medications per PI's discretion.
- The patient has any clinical signs or symptoms of infection per PI's discretion.
- The patient has hyperthermia or hypothermia.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Research Foundation
Houston, Texas, 77478
About this study
Official title: "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury"
This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury." under IND 027396.
- Conditions
- Brain Injury
- Being tested
- HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)Biological
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164482
- Sponsor's protocol ID
- HBBI01
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients With Traumatic or Nontraumatic Brain Injury"
- ClinicalTrials.gov ID
- NCT07164482
- Acronym / sponsor ID
- HBBI01
- Conditions
- Brain Injury
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access protocol is part of IND 031942 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of nontraumatic or traumatic brain injury for up to 8 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBBI01 clinical study protocol entitled, "An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs for the Treatment of Patients with Traumatic or Nontraumatic Brain Injury." under IND 027396.
Study design
Who may qualify
- Ages
- 14 to 78 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female patients 14 - 78 years of age
- 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.
- 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:
- 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:
Key exclusion criteria (7 listed)
- Women who are currently pregnant or lactating.
- The patient has any active infection requiring medications per PI's discretion.
- The patient has any clinical signs or symptoms of infection per PI's discretion.
- The patient has hyperthermia or hypothermia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) in people with Brain Injury, run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.