Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT04064957
Eligibility Criteria:
HBSCI02:
Inclusion Criteria:
1. Adult individual 18 yr. of age or older.
2. Cognitively intact and capable of giving informed consent.
3. Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine
4. Patient and Caregiver agree to use Care Connect app or web version of VirTrial platform for virtual visits.
Exclusion Criteria:
1. Prior history of:
1. Recent or ongoing infection,
2. Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease,
3. Neurodegenerative disorders,
4. Cancer,
5. Immunosuppression as defined by WBC \< 3, 000 cells/ml at baseline screening,
6. Chemical or ETOH dependency,
2. Having a contraindication to MRI scans
3. Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSC administration
4. Participation in other interventional research studies.
5. Unwillingness to return for follow-up visits
HBSCI04:
Inclusion Criteria:
1. Adult individual 18 years of age or older.
2. Cognitively intact and capable of giving informed consent.
3. Clinical diagnosis of Spinal Cord Injury.
4. Subject has mesenchymal stem cells banked at Hope Biosciences.
5. The patient accepts to receive treatment and to comply with follow-up visits.
Exclusion Criteria:
1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation.
2. Active Alcohol or Drug addiction.
3. Participation in concurrent interventional research studies during this study.
4. Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
5. Unwillingness to return for follow-up visits.
HBSCI05:
Inclusion Criteria:
1. Adult individual 18 years of age or older.
2. Cognitively intact and capable of giving informed consent.
3. Clinical diagnosis of Spinal Cord Injury.
4. Subject has mesenchymal stem cells banked at Hope Biosciences.
5. The patient accepts to receive treatment and to comply with follow-up visits.
Exclusion Criteria:
1. Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation.
2. Active Alcohol or Drug addiction.
3. Participation in concurrent interventional research studies during this study.
4. Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
5. Unwillingness to return for follow-up visits.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04064957
Study Brief:
Protocol Section:
NCT04064957