Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cell Therapy for Chronic Spinal Cord Injury (HBSCI02), Individual Patient Expanded Access IND to Evaluate the Safety and Efficacy of HB-adMSCs for the Treatment of Spinal Cord Injury (HBSCI04 & HBSCI05)
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
HBSCI02:
This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about 4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was immediately unable to move his legs. He discharged to Texas via air ambulance for physical rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury Association) C-5 SCI (spinal cord injury).
HBSCI04:
This Individual Patient Expanded Access IND has been created per the request of a 75-year-old man who has been diagnosed with Spinal Cord Injury. The patient requested this Expanded Access IND with the purpose of possible restoration of nerve transmission and restoring sensation in his upper and lower body using intravenous autologous adipose derived mesenchymal stem cells.
HBSCI05:
This Individual Patient Expanded Access IND has been created per the request of a 26-year-old man who has been diagnosed with Spinal Cord Injury. The patient is a 26-year-old male who suffered an unstable C-6 compressive fracture, crushing the vertebral body and retropulsion of a large bone fragment into the vertebral canal, stenosing 75% of spinal canal in a diving accident on 12/4/2021 in Belize City, Belize. The injury classification is C-6 Asia A injury. The injury left him with flaccid paralysis below the level of C-7 dermatome.
详细描述
HBSCI02:
Once the eligibility is confirmed, approximately 1-3 weeks after the screening/baseline visit, the subject will receive the first infusion. Subsequent treatments will occur every other week in the subject's home, administered by a nurse.
On each of these visits, the subject will receive one autologous HB-adMSC infusion of 200 million (2 x 10^8 cells) total cells. Every infusion visit will include the following procedures:
- Interval H&P and concomitant medications update.
- QOL and Disability (SCIM self eval) surveys will be completed by the subject with the assistance of the primary caregiver.
- Vital signs monitoring will be initiated (Heart Rate, BP, Resp., Temp., SpO2).
- A peripheral IV line will be inserted.
- A blood sample for clinical labs will be drawn monthly during the infusion period.
- A "time out" verification of patient/consent/procedure/cell product will be performed.
- The HB-adMSC infusion will be given by through the peripheral IV.
- Assessment for Infusion Related AE/SAEs.
- The subject will be monitored for a minimum of 2 hours.
In-Person Visits The subject will return to the Clinical Trial Network CTN site for In-Person visits to occur at Screening, Baseline and Week twelve (12), twenty-six (26) and at Week fifty-two (52). Week 52 visit will serve as the End of Study visit. The end of study (EOS) visit will include an MRI of the c-spine as well as all of the study procedures for Follow-up Visits without Infusion. A written summary of the results of the treatment, including adverse events will be submitted to the FDA after completion of the last follow-up visit.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individual 18 yr. of age or older.
- •Cognitively intact and capable of giving informed consent.
- •Clinical diagnosis of a non-penetrating traumatic SCI to the cervical spine
- •Patient and Caregiver agree to use Care Connect app or web version of VirTrial platform for virtual visits.
排除标准
- •Prior history of:
- •Recent or ongoing infection,
- •Clinically significant cardiovascular, lung, renal, hepatic, or endocrine disease,
- •Neurodegenerative disorders,
- •Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening,
- •Chemical or ETOH dependency,
- •Having a contraindication to MRI scans
- •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
- •Participation in other interventional research studies.
- •Unwillingness to return for follow-up visits
- •Inclusion Criteria:
- •Adult individual 18 years of age or older.
- •Cognitively intact and capable of giving informed consent.
- •Clinical diagnosis of Spinal Cord Injury.
- •Subject has mesenchymal stem cells banked at Hope Biosciences.
- •The patient accepts to receive treatment and to comply with follow-up visits.
- •Exclusion Criteria:
- •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.
- •Active Alcohol or Drug addiction.
- •Participation in concurrent interventional research studies during this study.
- •Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
- •Unwillingness to return for follow-up visits.
- •Inclusion Criteria:
- •Adult individual 18 years of age or older.
- •Cognitively intact and capable of giving informed consent.
- •Clinical diagnosis of Spinal Cord Injury.
- •Subject has mesenchymal stem cells banked at Hope Biosciences.
- •The patient accepts to receive treatment and to comply with follow-up visits.
- •Exclusion Criteria:
- •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.
- •Active Alcohol or Drug addiction.
- •Participation in concurrent interventional research studies during this study.
- •Severe organ failure (heart, kidney or liver) confirmed by additional tests or medical history.
- •Unwillingness to return for follow-up visits.