Exciting Times For Spinal Cord Injury Clinical Trials …
By LizaAVILA
These are indeed exciting times for spinal cord injury (SCI) clinical trials. There are trials ongoing around the world targeting different repair strategies. In this article we want to take the opportunity to explain some of the high profile clinical trials ongoing in the United States utilizing cells as a therapeutic intervention.
Miami Project Schwann Cells
As many of our readers know, The Miami Projects 1st Phase I clinical trial testing Schwann cells began in November 2012 and we are happy to announce that the final participant was transplanted in August 2015. Schwann cells come from your own body and they are a type of cell found throughout the entire peripheral nervous system (PNS). The PNS includes all nerves going out to muscles as well as sensory nerves coming from the muscles back to the spinal cord. Schwann cells are a type of support cell in the PNS and some important points about Schwann cells are that they 1) insulate (myelinate) individual nerve fibers (axons), which is necessary for sending appropriate electrical signals throughout the nervous system, 2) are not stem cells, they are adult cells and can only be Schwann cells, and 3) can be obtained from each persons own body thereby eliminating the need for immunosuppression medicine.
This trial is specifically targeting people with new SCI, less than 30 days after injury, having sustained a trauma-induced lesion between thoracic levels T3-T11 and whom were neurologically complete. This is a dose escalation treatment trial, meaning that we will test 3 different doses: 5 million, 10 million, and 15 million Schwann cells. There were a total of 39 people screened for eligibility, 9 were enrolled, and 6 participants were transplanted. The first two participants received the 5 million cell dose, the second two received the 10 million cell dose, and the final two received the 15 million cell dose. Thus far, there have been no treatment-related adverse effects in any of the transplanted subjects, which is excellent news. Remember, safety is the determinate of success for this phase I trial. We are not releasing any other information about the participants or results because the trial is still ongoing and we cannot compromise the data. After the final participant is 12 months post-transplant we will prepare the results for publication in a peer-reviewed scientific journal.
Our 2nd Phase I clinical trial began in February 2015 for chronic SCI and will also be primarily focused on safety, but in addition it will involve a preliminary evaluation of the efficacy of combining Schwann cells with exercise and rehabilitation. For humans with chronic SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of autologous Schwann cells. In addition, spinal cord cavitation may be reduced and neural sprouting and plasticity may be enhanced via neurotrophic effects. In this trial, participants will receive three months of fitness conditioning and locomotor rehabilitation prior to transplantation in order to validate the stability of their neurological baseline as well as to enhance their fitness level thereby reducing any deconditioning effects. They will also receive fitness conditioning and rehabilitation for six months post-transplantation to maintain health and promote neuronal activity and potential neuroplasticity. We believe that this combination of cell therapy with intense rehabilitation prior to and following cell transplantation will enhance our chances of seeing improved recovery in the chronic setting https://clinicaltrials.gov/ct2/show/NCT02354625 .
StemCells Inc
Drs. Allan Levi and Kim Anderson, along with several other University of Miami faculty members, are also participating in a clinical trial testing a different cell therapy neural stem cells. That trial, referred to as the Pathway Study, is sponsored by a company called StemCells, Inc.
The Pathway Study is testing the safety and potential benefit of a very specific stem cell type known as a neural stem cell; these are not Schwann cells. The neural stem cells being used in the Pathway Study were derived from fetal brain tissue and have the ability to self-renew and become the main types of mature cells found both in the brain and spinal cord. These cells do not come from your own body, therefore anyone who receives them into their body has to be on immunosuppression medicine. Studies of SCI in animals have shown that these human neural stem cells can survive and lead to recovery of function through remyelination and possibly neuronal cell replacement.
Prior to the Pathway Study, the company conducted a Phase I/II safety & preliminary efficacy clinical trial in humans with thoracic SCI. Twelve participants were transplanted within 3 to 12 months of injury. The results they have disclosed at scientific meetings indicate that neural stem cell transplantation appears to be safe; several participants have regained some sensation.
The Pathway Study is a larger Phase II efficacy clinical trial designed to determine if neural stem cells can help people with cervical SCI recover spinal cord function and gain strength and sensation. They will enroll up to 52 participants. Individuals may be able to join the study if they are 18 to 60 years old, have a cervical SCI that is classified as ASIA Impairment Scale grade A, B, or C, are less than two years post-injury, and are generally in good health. Individuals that are eligible for the study will participate for approximately 12 months. There are several sites around the country that are enrolling https://clinicaltrials.gov/ct2/show/NCT02163876 .
Asterias Biotherapeutics
Many of you have probably heard of the Geron clinical trial that was prematurely halted a few years ago for financial reasons. In 2013, a new company called Asterias Biotherapeutics took over the rights for everything related to the prior trial. The first trial was a Phase I safety trial using a human embryonic stem cell line pre-differentiated into oligodendrocyte progenitor cells. The oligodendrocyte progenitor cells are targeting reduction of the size of the injury cavity as well as remyelination of demyelinated axons to restore conduction. These cells also cannot be obtained from your own body, hence require immunosuppression medicine as well when administered to anyone. In that trial, 5 individuals with complete thoracic injury received the cells within 14 days after their injury. The results they have disclosed at scientific meetings indicate that the cell transplantation appears to be safe and that four of the five participants appear to have a smaller cavity when evaluated by MRI.
In 2015, they began a Phase I/IIa dose escalation trial, the SCI-Star study. This trial is enrolling individuals with cervical injury between levels C5-C7 whom are neurologically complete. The cells have to be injected between 14 to 30 days post-injury; up to 13 participants will receive the cells. There are at least 3 centers enrolling https://clinicaltrials.gov/ct2/show/NCT02302157 .
Neuralstem
The final cell therapy of high profile is being conducted by a company called Neuralstem. This is a Phase I safety trial using human fetal spinal cord neural precursor cells. These stem cells are targeting growth factor replacement and possibly neuronal cell replacement. Again, because these cells do not come from ones own body, they require immunosuppression medicine. The company previously completed a Phase I safety trial using the same cells in individuals with Lou Gehrigs disease. They transplanted 18 participants in mid- to late stages of the disease and demonstrated safety. The company then obtained approval for the SCI Phase I trial. A total of 4 participants with complete thoracic injury, between one and two years post-injury, will be transplanted. The study procedures are all performed in California https://clinicaltrials.gov/ct2/show/NCT01772810 .
To find out more information about the trials being conducted at The Miami Project, contact The Miami Project Education Department at 305-243-7108 or MPinfo@med.miami.edu . More information about all of our clinical trials and studies is available at http://www.themiamiproject.org/trials .
Read the original here:
Exciting Times For Spinal Cord Injury Clinical Trials ...
- 001 Paralyzed rat walks with own stem cells in 11 wks. [Last Updated On: July 11th, 2011] [Originally Added On: July 11th, 2011]
- 002 Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman [Last Updated On: August 9th, 2011] [Originally Added On: August 9th, 2011]
- 003 Non-controversial Stem Cells: Rationale for Clinical Use: Neil Riordan, Ph.D. - Miami, FL [Last Updated On: September 4th, 2011] [Originally Added On: September 4th, 2011]
- 004 Cure for blindness - retina repair using stem cells. Future health keynote speaker [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- 005 Geron's Embryonic Stem Cell Clinical Trial for Spinal Cord Injury [Last Updated On: September 6th, 2011] [Originally Added On: September 6th, 2011]
- 006 William Rader MD - Paralyzed Spinal Cord Injury Patient Walks Again [Last Updated On: September 7th, 2011] [Originally Added On: September 7th, 2011]
- 007 Adult Stem Cell Sucess Stories - Laura Dominguez [Last Updated On: September 7th, 2011] [Originally Added On: September 7th, 2011]
- 008 Spinal Cord Injury Treatment With Stem Cells [Last Updated On: September 9th, 2011] [Originally Added On: September 9th, 2011]
- 009 Over Comes Spinal Cord Injury - No Surgery or Stem Cells http://www.releasetechnique.com [Last Updated On: September 10th, 2011] [Originally Added On: September 10th, 2011]
- 010 Non-controversial Stem Cells: Rationale for Clinical Use - Dr. Neil Riordan [Last Updated On: September 11th, 2011] [Originally Added On: September 11th, 2011]
- 011 Stem Cells Therapy for Spinal Cord Injury.flv [Last Updated On: September 12th, 2011] [Originally Added On: September 12th, 2011]
- 012 Walking after Spinal Cord injury and Stem Cells [Last Updated On: September 16th, 2011] [Originally Added On: September 16th, 2011]
- 013 Stem Cells May Reverse Paralysis, Brain Damage, and Organ Failure [Last Updated On: September 18th, 2011] [Originally Added On: September 18th, 2011]
- 014 The Usefulness of Adult Olfactory Stem Cells in Spinal Cord Injury and Brain Injury [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- 015 Stem cells for Parkinson's Disease, Spinal Cord Injury [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- 016 Embryonal Stem Cells Promote Functional Recovery in Spinal Injured Animals [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- 017 First Spinal-Cord Surgery With Stem Cells [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- 018 Medra Inc - Paralyzed Spinal Cord Injury Patient Walks Again [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- 019 Spinal Cord Injury - Embryonic Stem Cells - Dr. Keirstead [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- 020 Stem cell treatment by Adiva Health Care India after Spinal Cord Injury [Last Updated On: September 29th, 2011] [Originally Added On: September 29th, 2011]
- 021 Embryonic Stem Cells Cure Spinal Cord Injury? [Last Updated On: October 1st, 2011] [Originally Added On: October 1st, 2011]
- 022 Stem Cells for Spinal Cord Injury [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 023 Stem Cells and Neurogenesis [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 024 Stemcells come alive: Fix Mouse with severed spine ABCnews [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 025 The Spinal Cord Journey - Stem cell therapy stories from three spinal cord injury patients [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 026 Spinal Cord Injury patient 10 years after injury after Stem Cell Treatment [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 027 StemCells Gains 5% on Neural Stem Cell Trial in Spinal Cord Injury [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 028 The Promises of Neural Stem Cells in Motor Neuron Disease [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 029 Stem Cell Series: Part 3 [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 030 Christopher "Kit" Bond - Spinal Cord Injury Stem Cell Patient [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 031 Roman Reed: What all patient advocates at the World Stem Cell Summit should know [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 032 Noah Stem Cell Transplant Day 3 [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 033 Spinal Patient Receives Stem Cells in First Experimental Treatment [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 034 Health and Home Stem-1 [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 035 UK's first approved adult stem cell bank Oristem® explained [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 036 Stem Cells: Hope, Hype and Progress - Session 1b [Last Updated On: October 8th, 2011] [Originally Added On: October 8th, 2011]
- 037 Stem Cells: Hope, Hype and Progress - Session 3 - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- 038 Human Trials of Embryonic Stem Cell Treatment Beginning - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 039 (Film Trailer) - The Spinal Cord Journey: Stem Cell Therapy Stories of Recovery - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- 040 Stem Cell Treatment for Spinal Cord Injury - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 041 Public Symposium: The Stem Cell Promise: Moving to the Clinic - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 042 Stem Cells: Hope, Hype and Progress - Session 1a - Video [Last Updated On: October 29th, 2011] [Originally Added On: October 29th, 2011]
- 043 Stem Cell Treatment for T-6 Spinal Cord Injury - Video [Last Updated On: October 29th, 2011] [Originally Added On: October 29th, 2011]
- 044 Tamara Marquis - SCI Stem Cell Patient - Video [Last Updated On: October 31st, 2011] [Originally Added On: October 31st, 2011]
- 045 Stem Cells - Treatment for Spinal Cord Injury - Video [Last Updated On: October 31st, 2011] [Originally Added On: October 31st, 2011]
- 046 Electro-Medicine : Biological Physics - Paralysis Spinal Chord Injury Treatment - Video [Last Updated On: November 10th, 2011] [Originally Added On: November 10th, 2011]
- 047 Biological Physics : Stem Cells - Paralyzed Spinal Cord Injury Patient Walks Again - Video [Last Updated On: November 10th, 2011] [Originally Added On: November 10th, 2011]
- 048 Innovative stem cell treatment for Spinal Cord Injuries - Video [Last Updated On: November 22nd, 2011] [Originally Added On: November 22nd, 2011]
- 049 Stem Cells Treatment for Spinal Cord Injuries, Successfully Results, Stem Therapy - Video [Last Updated On: November 23rd, 2011] [Originally Added On: November 23rd, 2011]
- 050 Gabi - SCI Stem Cell Patient - Video [Last Updated On: November 23rd, 2011] [Originally Added On: November 23rd, 2011]
- 051 Stem Cell Treatment for Spinal Cord Injury - Patient Interview - Video [Last Updated On: December 7th, 2011] [Originally Added On: December 7th, 2011]
- 052 StemCellTV Daily Report-November 22, 2011 - Video [Last Updated On: December 14th, 2011] [Originally Added On: December 14th, 2011]
- 053 Which Stem Cell Will Win The Race To Repair The Spinal Cord? - Video [Last Updated On: December 23rd, 2011] [Originally Added On: December 23rd, 2011]
- 054 China medical tourism--spinal cord injury--stem cells therapy - Video [Last Updated On: December 27th, 2011] [Originally Added On: December 27th, 2011]
- 055 MouseVideo-SCI - Video [Last Updated On: January 1st, 2012] [Originally Added On: January 1st, 2012]
- 056 Explaining stem cells - Video [Last Updated On: January 3rd, 2012] [Originally Added On: January 3rd, 2012]
- 057 China medical tourism--Spinal Injury--Stem Cell - Video [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- 058 Stem cell therapy at VMC - Video [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- 059 Breakthrough Spinal Cord Injury Treatment - Stem Cell Of America - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- 060 Stem cell treatments change girl's life [Last Updated On: February 14th, 2012] [Originally Added On: February 14th, 2012]
- 061 Neuralstem Announces Closing of $5.2-Million Registered Direct Offering [Last Updated On: February 15th, 2012] [Originally Added On: February 15th, 2012]
- 062 Stem-cell scientists find right chemistry [Last Updated On: February 19th, 2012] [Originally Added On: February 19th, 2012]
- 063 Panamanian-US Scientific Research Supports Using Fat Stem Cells to Treat Rheumatoid Arthritis [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- 064 Qatari students to present research on stem cells [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- 065 Bioethics Backlash [Last Updated On: February 23rd, 2012] [Originally Added On: February 23rd, 2012]
- 066 Waisan Poon, "Clinical trial of umbilical cord blood stem cells in spinal cord injury" - Video [Last Updated On: February 23rd, 2012] [Originally Added On: February 23rd, 2012]
- 067 Osamu Honmou, "Transplantation of bone marrow stem cells" - Video [Last Updated On: February 23rd, 2012] [Originally Added On: February 23rd, 2012]
- 068 Dah-Ching Ding, "Human umbilical cord mesenchymal stem cells support prolonged expansion of... - Video [Last Updated On: February 23rd, 2012] [Originally Added On: February 23rd, 2012]
- 069 Stem Cell Action Coalition Opposes Virginia Personhood Bill [Last Updated On: February 24th, 2012] [Originally Added On: February 24th, 2012]
- 070 Adding Six More, Omeros Now Has a Total of 33 Unlocked Orphan GPCRs in its Portfolio [Last Updated On: February 29th, 2012] [Originally Added On: February 29th, 2012]
- 071 It's not pulp fiction [Last Updated On: March 4th, 2012] [Originally Added On: March 4th, 2012]
- 072 Cryo-Cell's Affiliate, Saneron CCEL Therapeutics, Releases Pre-clinical Data Indicating That Cord Blood Stem Cells ... [Last Updated On: March 6th, 2012] [Originally Added On: March 6th, 2012]
- 073 Will StemCells Walk The Talk? [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- 074 Young aims for spinal injury 'cure' [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- 075 Doctor looks to China for spinal injury 'cure' [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- 076 Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- 077 Neuralstem Shows Solid Progress in Spinal Cord Neural Stem Cell Trial for ALS [Last Updated On: March 8th, 2012] [Originally Added On: March 8th, 2012]
- 078 Oklahoma bill proposes umbilical cord blood bank [Last Updated On: March 8th, 2012] [Originally Added On: March 8th, 2012]
- 079 Research suggests new therapeutic approach for spinal cord injury [Last Updated On: March 13th, 2012] [Originally Added On: March 13th, 2012]
- 080 Doctor looks to China for spinal injury ‘cure’ [Last Updated On: March 13th, 2012] [Originally Added On: March 13th, 2012]
