FDA Gives Green Light to Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Patients

FDA Gives Green Light to Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Patients

The U.S. Food and Drug Administration (FDA) has approved BrainStorm Cell Therapeutics‘ request to open a Phase 2 clinical trial testing the safety and effectiveness of its proprietary NurOwn mesenchymal stem cell (MSC) treatment in progressive multiple sclerosis (MS) patients.

The request was in the form of Investigational New Drug (IND) application, and BrainStorm plans to launch the study in early 2019.

“We are excited about the launch of early testing of this cell-based approach to treating progressive MS, for which there are few treatment options,” Bruce Bebo, executive vice president of research at the National MS Society, said in a press release. “We look forward to better understanding the potential benefits and safety of this and other cell-based therapies for MS.”

Stem cells have the ability to develop into different cell types, and to replace damaged or dying cells in the body. There are different types of stem cells, and therapies based on these cells are being investigated for several diseases, including MS.

NurOwn cells are MSCs obtained from a patient’s bone marrow — the spongy tissue inside bones — and grown in the lab under patented conditions in order to induce the cells to secrete high levels of neurotrophic factors (NTF), molecules that support the growth, survival, and differentiation of neurons. These MSC-NTF cells are then injected back into the patient intravenously or into the spinal canal.

Experiments with mice suggest that injected NurOwn stem cells do not themselves replace damaged cells. Instead, the lab treatment customizes MSCs, converting them into biological factories that secrete high levels of NTFs, which in turn encourage neural stem cells to replace damaged cells.

NTFs may also exert a therapeutic effect in progressive MS by other mechanisms. They can improve neuronal survival following injury, protecting cells from oxidative stress (an imbalance between the body’s production of potentially harmful reactive oxygen species and its ability to contain them), and they can modulate the immune response, shifting it from proinflammatory to anti-inflammatory, dampening the autoimmune damage done to myelin (the protective cover of neurons that is destroyed in MS).

Currently, no autologous cell therapies are FDA-approved to treat MS or other neurological diseases.

“We are excited to participate in this Phase 2 clinical trial and hope that this innovative cell therapy approach leads to a new treatment option for patients with progressive MS,” said Fred Lublin, MD, director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center. “We are particularly pleased to see a scientifically rigorous approach to advance the science of stem cell therapeutics.”

NurOwn cell therapy is currently being evaluated for safety and efficacy in a Phase 3 clinical trial (NCT03280056) in up to 200 people with amyotrophic lateral sclerosis (ALS) at sites in the U.S. This double-blinded and placebo-controlled study, which is recruiting eligible adults, administers the therapy three times bi-monthly via lumbar puncture (intrathecal injection) and is expected finish in July 2019.

The NurOwn technology was developed in the laboratories of  researchers at Tel Aviv University.

Alberto Molano was born in Bogotá, Colombia. He studied medicine at Universidad del Rosario and obtained a Ph.D. in Immunology from Weill Cornell Graduate School of Medical Sciences in New York. He conducted research and authored or co-authored twenty publications on molecular and cellular immunology, autoimmunity, immunology of aging and parasite immunology.
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Alberto Molano was born in Bogotá, Colombia. He studied medicine at Universidad del Rosario and obtained a Ph.D. in Immunology from Weill Cornell Graduate School of Medical Sciences in New York. He conducted research and authored or co-authored twenty publications on molecular and cellular immunology, autoimmunity, immunology of aging and parasite immunology.
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26 comments

  1. Jason says:

    Way to go America! You’re in last yet again. Places throughout the World are all ready doing it. Better late than never, I suppose.

  2. Seth says:

    So sad to learn i have ms then to learn almost NONE OF THE TREATMENTS are covered by insurance. If only i lived in Canada or France…

  3. Rodger Ashton-Smith says:

    I hope it will do the job, I am sick of the negative form of treating PPMS saying there is nothing for us. What are we supposed to do?

    • Perle says:

      I’m so sick of toxic meds for RRMS. I totally feel your pain here. Are you on Ocrevus? I am, for 2 yrs. I’m always sick w infections. I so want stem cell therapy.

  4. Rodger Ashton-Smith says:

    I hope they find something for us. I’m getting sick of the negative of the profession people telling me there is nothing for me. What am I supportive to do?

  5. Greg says:

    Agree with Rodger,here from doctor there nothing but Ocrevus for me. Coming up on 4th infusion,lost my job,walk with cane, worse than I ever had been!It was medicine overkill! Why USA is so behind on stem cells is pathetic.Always here”tryig to find a cure”.” HELLO McFLY IS THERE ANYBODY HOME”.

    • Perle says:

      Ummm….idiot politicians and anti-abortion wackos won’t let anyone do government funded research with human stem cells. Just send us the red hooded capes. The idiocy of it all.

  6. Marilyn Healey says:

    I have a 47 year old daughter who has suffered 30 years with this debilitating disease! Any new advance would be a god send and hope there will be a short time before we see this being offered in Canada. A concerned mother

    • Alberto Molano says:

      The national clinical trial identifier is NCT03799718. Go to that link. Read the inclusion and exclusion criteria carefully to know if you are eligible. Then click where it says “Contacts and Locations”.

  7. Deborah Houston says:

    I am begging for help for my daughter. She is allergic to all meds and is declining rapidly. Her neurologist Dr. Richman in Pinehurst NC is at a loss for treatment. I am not a wealthy woman and want to give my daughter every breath and moment on this earth that I can. I would give my own to help her. She is a 47 year old mom with a husband and children, and one of the loves of my life. I will do anything to get her help. Please can someone help me give her some quality of life.

  8. Sharon Castiel says:

    I am sadly part of the PPMS population and walking is getting harder and harder. I now use a walker and I am only 53. I would be interested in being involved in any clinical trial available to PPMS patients.

  9. Marianne Colella says:

    I would love to be part of trial. 61yr old female diagnosed in 2004 progressive now. On Ocrevus use power chair and walker.

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