Spontaneous Intracerebral HemorrhagePhase 1NCT05232903
Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).
A Phase 1 study testing SVF therapy group in people with Spontaneous Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH). Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- What is being tested?
- SVF therapy group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Sep 2024
- Phase
- Phase 1
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range: 45~55 years old
- Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
- Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT.
- Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
- Ability to provide written personal or surrogate consent.
- Expectancy life is longer than 12 months.
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- Subject must be available for all specified assessments at the study site through the completion of the study.
- Determining Organ function according to the following criteria:
- 1) Aspartate transaminase (AST) ≤2.5×Upper limit of normal 2) Alanine transaminase (ALT) ≤2.5×Upper limit of normal 3) Total bilirubin (T-Bil) ≤1.5×Upper limit of normal 4) Serum albumin (SA) ≥3.0g/dL 5) Absolute neutrophil count（ANC）≥1.5×10^9/L 6) Platelets (PLT) ≥150×10^9/L 7) Hemoglobin (Hb) ≥9.0g/dL 8) Creatine kinase (CK) ≤1.5×Upper limit of normal 9) Serum amylase (AMY) and serum lipase (Lip) are within the normal range
Who cannot join
- Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
- History of epilepsy.
- History of brain tumor.
- History of brain trauma.
- Pre-existing disability defined as a pre-stroke modified Rankin scale >2.
- Evidence of organ failure.
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- Septicemia with high fever and shock.
- Positive for any one of hepatitis B surface antigens, e antigens, e antibodies, and core antibodies, hepatitis C virus antibodies, syphilis antibodies, or HIV antibodies positive.
- Participation in any clinical investigation within 3 months prior to dosing.
- Suffer from any other clinically significant medical diseases or with evidence of metal disorder.
- The investigator or sponsor determines that participating in the trial will bring safety risks to the patients.
- Participated in other stem cell therapy research.
- History of drug or alcohol abuse in the past year
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Allergic to cattle and pork products.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100070
Yong Cao, M.D., 861067096510 ext. 100070, caoyong@bjtth.org
About this study
Official title: Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
Read the detailed description
Spontaneous intracerebral hemorrhage (SICH) is a form of brain parenchymal hemorrhage caused by various non-traumatic reasons, resulting in cerebral artery, veins or capillaries rupture. SICH is a common neurological emergency with the characteristics of rapid onset, dangerous conditions, and a high disability and fatality rate. Although the fatality rate has decreased, reflecting the progress of recent medical technologies, most patients still have persistent language or limb movement dysfunction.
Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Being tested
- SVF therapy group
- Keywords
- Spontaneous intracerebral hemorrhage, Stromal vascular fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVF therapy groupBiological
The active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV) | Experimental | Intravenous infusion of stromal vascular fraction (SVF) dose 0.5 x 10^6/kg for 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. Receives: Biological: SVF therapy group |
| Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV) | Experimental | Intravenous infusion of stromal vascular fraction (SVF) dose 1.0 x 10^6/kg for next 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. Receives: Biological: SVF therapy group |
| Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV) | Experimental | Intravenous infusion of SVF stromal vascular fraction (SVF) dose 1.5 x 10^6/kg for final 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. Receives: Biological: SVF therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.
Measured: 1 year
Secondary outcomes (3)
The changes in stroke-related neurologic deficit
The changes in stroke-related neurologic deficit were measured by the National Institute of Health stroke scale (NIHSS), which ranges from 0 to 45. Higher scores indicate worse neurological function.
Measured: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' language function
The changes in patients' language function were measured by the Western Aphasia Battery (WAB), which ranges from 0 to 100. Higher scores indicate better language function.
Measured: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' sensorimotor function
The changes in patients' language function were measured by the Fugl-Meyer Assessment (FMA), which ranges from 0 to 226. Higher scores indicate better language function.
Measured: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232903
- Sponsor's protocol ID
- SICH-SVF
- Status last verified
- Feb 2022
- First submitted
- 6 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT05232903
- Acronym / sponsor ID
- SICH-SVF
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- Spontaneous intracerebral hemorrhage, Stromal vascular fraction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Feb 2022 (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.
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
Detailed description
Spontaneous intracerebral hemorrhage (SICH) is a form of brain parenchymal hemorrhage caused by various non-traumatic reasons, resulting in cerebral artery, veins or capillaries rupture. SICH is a common neurological emergency with the characteristics of rapid onset, dangerous conditions, and a high disability and fatality rate. Although the fatality rate has decreased, reflecting the progress of recent medical technologies, most patients still have persistent language or limb movement dysfunction.
Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV) | Experimental | Biological: SVF therapy groupIntravenous infusion of stromal vascular fraction (SVF) dose 0.5 x 10^6/kg for 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. |
| Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV) | Experimental | Biological: SVF therapy groupIntravenous infusion of stromal vascular fraction (SVF) dose 1.0 x 10^6/kg for next 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. |
| Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV) | Experimental | Biological: SVF therapy groupIntravenous infusion of SVF stromal vascular fraction (SVF) dose 1.5 x 10^6/kg for final 5 participants within 1 month after neurosurgical intracerebral hemorrhage (ICH) evacuation. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age range: 45~55 years old
- Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
- Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT.
- Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
- Ability to provide written personal or surrogate consent.
Key exclusion criteria (15 listed)
- Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
- History of epilepsy.
- History of brain tumor.
- History of brain trauma.
- Pre-existing disability defined as a pre-stroke modified Rankin scale >2.
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 |
|---|---|---|
| SVF therapy groupThe active treatment is an intravenous injection with the stromal vascular fraction (SVF) harvested from the patient's own fatty tissue. | Biological | Group 1 SVF dose 0.5 x 10^6/kg Intravenous infusion (IV), Group 2 SVF dose 1.0 x 10^6/kg Intravenous infusion (IV), Group 3 SVF dose 1.5 x 10^6/kg Intravenous infusion (IV) |
Primary outcome
Occurrence of adverse events
Time frame: 1 year
Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.
3 secondary outcomes
The changes in stroke-related neurologic deficit
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' language function
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
The changes in patients' sensorimotor function
Time frame: baseline, Month 1, Month 3, Month 6, Month 9, Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SVF therapy group in people with Spontaneous Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
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 9 inclusion and 15 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 2 Mar 2022. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yong Cao, M.D. (861067096510 ext. 100070, caoyong@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 2 Mar 2022.