Clinical Trial Study: Chronic Complete Spinal Cord Injury Trial to Begin Soon
Are you ready for a clinical trial treating chronic complete spinal cord injury patients? How about a clinical trial like that being conducted in the United States? Well, the time has come!
Dr. Wise Young has been conducting clinical trials for chronic spinal cord injury in China for several years and those trials are now starting here in the United States!
Dr. Young's Phase IIb clinical trial will test the effectiveness of treating people having a chronic complete spinal cord injury with umbilical cord blood cells, lithium, and intense walking training.
This trial is set to begin yet in 2019!
Read on to learn more!
About Dr. Wise Young
Wise Young, M.D., Ph.D. has worked tirelessly throughout his career in search of a curative therapy for people with spinal cord injury. He is a distinguished professor, founding director of the W.M. Keck Center for Collaborative Neuroscience at Rutgers University, and one of the world's most distinguished neuroscientists.
Dr. Young has built and trained a network of 25 clinical trial centers in Taiwan, Hong Kong, and China where his umbilical cord blood mononuclear cell and lithium human clinical trials have taken place.
"In the initial results from the phase II trial in Kunming, China, 75% of the participants (15 out of 20) recovered walking with a rolling walker. www.keck.rutgers.edu
Details About the Clinical Trial
Specific very detailed information about this umbilical cord chronic spinal cord injury clinical trial can be found at clinicaltrials.gov but I will list the trial groups, schedule, inclusion criteria, and exclusion criteria here so you can better assess your interest and if you qualify.
To learn how to sign up, read on!
To assure the greatest accuracy, I copied the inclusion and exclusion criteria directly from the clinicaltrials.gov listing.
Trial Groups (9 people per group)
Surgery with cells + 6 weeks of oral lithium + 6 months of walking training
Surgery with cells + 6 months of walking training. No lithium.
6 months of walking training. Initially no cells or walking training.
After 6 months, those in this group can receive the surgery and cells with or without lithium plus additional walking training.
Participant spends 3 days in the hospital for surgery followed by a 2 week break at home while the incision heals. During this time the participant will stand at least one hour per day in a standing frame. After the two-week period, the participant will return to their surgeon to have the stitches removed.
Participant undergoes standing and stepping training on an outpatient basis at a rehabilitation facility. During this period standing is increased to 6 hours per day and step training begins.
Participant undergoes stepping training as an outpatient at a rehabilitation facility. Participant begins assisted walking in Rifton and/or Kunming rolling walker until they advance to minimally assisted walking.
Participant undergoes walking training indoors at Education Services Commission Facility in Piscataway and/or outdoor walking at Johnson and Buccleuch parks.
Participant returns home and continues walking at least one hour per day.
Follow-up at 6 and 12 months.
- Male and females ≥18 to ≤60 years of age.
- Traumatic SCI at a neurological level (the lowest contiguous spinal cord segmental level that has intact motor and sensory score) between C5 and T11. Note: For the first three subjects at each study center, the neurological level of SCI will be limited to thoracic region (between T1 and T11).
- Subjects with chronic SCI (defined as ≥ 12 months post- initial SCI surgery) with stable neurologic findings for at least six months and be able stand at least 1 hour/day using a standing frame, tilt table, or equivalent device.
- Subjects with a current neurological status of ASIA impairment grade A (complete).
- The injured site of the spinal cord is within three vertebral levels as confirmed by MRI scan.
- Subject must be in good enough physical health to tolerate the surgery and participate in the intensive walking program.
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- Both male and female subjects and their partners of childbearing potential must agree to use medically accepted methods of contraception.
- Willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
- Clinically significant renal, cardiovascular, hepatic and psychiatric diseases or other conditions that may increase risk of complications during or after surgery or may reduce the ability of the patient to participate in intense locomotor training based on the medical judgment of the investigator.
- Presence of any clinically significant medical condition(s) or infection (including but not limited to the carrier of hepatitis B virus or HIV) that, in the opinion of the Investigator, could interfere with the treatment or participation in the study.
- Subjects with flaccid paralysis with absence of deep tendon reflexes in the legs, severe atrophy of the lower limbs, or other evidence of lumbosacral injury, peripheral nerve injury, and motoneuronal loss.
- Fracture of weight-bearing bones and joints. These include fractures of femur, tibia, and fibula, as well as the ankle, knee, or hip joints. If such fractures have healed, the patient can be included in the trial.
- Injury to brain, peripheral nerve, or muscle that may interfere with neurologic or walking assessment.
- Pregnant or lactating woman.
- Syringomyelic cyst >30% of the cord diameter.
- Unavailability of HLA-matched umbilical cord blood cells.
- Current or recent (within 1 month) treatment with lithium.
- Any contraindication of laminectomy operation, lithium carbonate therapy or locomotor training.
- Taking medication that may interfere with lithium clearance, such as diuretics, NSAIDs (except acetoaminophen or Tylenol), nitroimidazole antibiotics or medications that has clinically important interactions with lithium.
- Subjects with abnormal renal function, thyroid or parathyroid levels, cardiovascular disease, depression at screening will be excluded, if considered clinically significant by the Principal Investigator.
- Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks before screening for this study.
- Any other criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate in this study.
A Phase IIb Trial
Dr. Wise Young's umbilical cord blood clinical trial is a Phase IIb trial.
Clinical trials are divided into phases: Phase I, Phase II (sometimes divided into phase IIa and IIb), Phase III (may also contain IIIa and IIIb), and Phase IV.
- Phase I: The first time something is tried in human subjects. Conducted with no less than 10 participants. Used to determine if a product or procedure is safe.
- Phase II: A drug or procedure is tested in patients with the affected disease or condition to determine efficacy (if the desired results can be achieved) and safety.
- Phase IIa: Determines short-term safety and efficacy of a drug or procedure.
- Phase IIb: Determines efficacy, safety and therapeutic dose range. Phase IIb are often considered the pivotal point in a study and usually serve as the most rigorous depiction and display of efficacy.
- Phase III: Drug or procedure is used in a large group (could number in the thousands depending on what it's for) and are randomized controlled studies. Investigates all aspects of treatment including benefit/risk ratio. The results will determine if a product or procedure is refused or registered for use in humans.
- Phase IV: Performed after a product or procedure is approved by the FDA for human use. Often called post-marketing (or post-registration) studies. Used to compare with other products or procedures in the same market.
Clinical Trial Funding
Once the science of something gets through pre-clinical trials (not in humans) the biggest hurdle getting to human clinical trials is most often money. Human clinical trials cost a boatload of money!
Dr. Young predicts the first year of this clinical trial will cost over $5 million! Add in the second year which will include data collection and analysis plus the cost of treating participants from the initial "walking only" group, the total will likely be around $7 million!
In case you're wondering at this point if you as a participant would have to pay into this $7 million, the answer is no. Clinical trial treatment is free of charge.
StemCyte, a global cord blood therapeutics company, is sponsoring Dr. Young's clinical trial to test umbilical cord blood mononuclear cells in chronic complete spinal cord injury patients. Jonas Wang, the CEO and chairman of the board of StemCyte is making efforts to raise $15 million for this current Phase II trial. In addition, he is planning the first initial public offering (IPO) of StemCyte in an effort to raise $30 million for potential Phase III trials.
Recent Video with Dr. Young
Here is a very recent video of Dr. Wise Young discussing absolutely everything you would want to know about him and this clinical trial.
The video is near an hour in length but definitely worth the watch!
How to Apply for the Clinical Trial
This clinical trial is not yet open for enrollment. Dr. Young indicates they expect to start December 2019.
You can read all of the detailed information about this trial at clinicaltrials.gov. Information here will again include groups (with more detail), timeline, inclusion and exclusion criteria, as well as information about clinic centers. The listing on clinicaltrials.gov will also contain information regarding how to apply.
If you are on Dr. Young's eBulletin list you will receive an email once the application process is opened. To get on this emailing list send your name and email address to firstname.lastname@example.org.
Frequently Asked Questions
Dr. Wise and his crew are finding there are many commonly asked questions about the clinical trial in general as well as specific questions regarding the walking training included in this trial.
Click the image below to read the Frequently Asked Questions sheet as well as the Questions regarding the Walking Program information sheet.
If yould like to read the scientific paper from Dr. Wise Young's earlier clinical trials click on the title below.
This is a very exciting time in spinal cord injury research! Never before in the history of the United States has a child like this been conducted.
I look forward to the start of this clinical trial but it could mean for those of us with a chronic spinal injury.
You can rest assured I will keep you updated!