Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience | BMT Infonet – BMT Infonet |

How to Support theUnique Psychosocial Challenges of Stem Cell Transplantand CAR T-cell Therapy Patients and Their Care Partners Mental Health Professionals: Earn 7 continuing education credits Why Take this Course? "I learned, as a transplant recipient, that a therapist is not a therapist is not a therapist. Working with a therapist who understands stem cell transplant is a completely different animal than working with an excellent therapist who doesnt have that knowledge base. I didnt have to explain the transplant experience. We could hit the ground running with our therapy. Nancy, stem cell transplant recipient.

Hematopoietic stem cell transplantation (HCT), also calledbone marrow, stem cell and cord blood transplantation, andCAR T-cell therapy, are two intensive therapies used to treat patients with advanced hematologic malignancies and certain genetic/immune system disorders. The intensity of the treatment, compared to standard chemotherapy for cancer patients, generates a unique set of medical and psychosocial consequences that are critical for mental health professionals (MHPs) to understand in order to most effectively support and treat these patients and their care partners.

This course is intended for psychologists, social workers, mental health counselors, and therapists. The instructional level isintermediate. We assume that participants already have psycho-oncology educational background and experience.

The primary format is a non-interactive distance-learning continuing education course presented through a series of videos.

Module 1: The Nuts and Bolts of Hematopoietic Cell Transplantation (HCT)John Wingard, MD; Michelle Bishop, PhD;Justin Regan, RN A broad overview of HCT including the rationale for its use; eligible patients; short-term, long-term, and late effects of treatment; and the impact on patients and care partners overall quality of life (QOL) and health behaviors.Includes an in-depth review of the psychosocial issues experienced by HCT patients and care partnersand concludes with a brief presentation by an HCT patient discussing the challenges both he and his family faced while undergoing and surviving two stem cell transplants.

Module 2: Autologous HCT: A Deeper Dive R. Gregory Bociek MD, MSc An in-depth review of the medical processes and the short- and long-term consequences of undergoing an autologous HCT. Autologous HCT is a transplant that uses the patients own stem cells. It is a treatment option for some patients diagnosed with multiple myeloma, non-Hodgkin lymphoma, Hodgkin disease and some solid tumors.

Module 3: Allogeneic HCT: A Deeper Dive Minoo Battiwalla MD, MS An in-depth review of the medical processes and the short-and long-term consequences of undergoing an allogeneic HCT. Allogeneic HCT uses stem cells provided by a donor, rather thanthe patient. It is a treatment option forsome patients diagnosed with leukemia, myelodysplastic syndrome, a myeloproliferative disorder, severe aplastic anemia, or an inherited disorder such as sickle cell disease.

Module 4: Unique Psychosocial Challenges for Autologous and Allogeneic HCT Patients and Care PartnersElizabeth M. Muenks, PhD A comparison of the psychosocial issues experienced by autologous HCT patients,allogeneic HCT patients, and their care partners during preparation for HCT, the day of transplant and early recovery, the first 100 days after HCT, and long-term.

Module 5: Graft-versus-Host Disease (GVHD): Trading an Acute Disease for a Chronic Disease Amin M. Alousi, MD;Michelle Bishop, PhD An overview of GVHD, a major complication that affects approximately 50%of patients who undergo an allogeneic HCT.This module includes an in-depth discussion of how GVHD affects multiple organs and tissues, treatment options and their potential side effects, and the psychosocial consequences of livingwith GVHD in the short- and long-term for both patients and care partners.

Module 6: Psychiatric Disorders in Patients Undergoing HCTMaria Adelaida Rueda-Lara, MD A review of common psychiatric issues that occur during and after HCT, and their management.

Module 7: CAR T-cell Therapy: The Medical and Psychosocial Experience Areej El-Jawahri, MD An in-depth review of the medical and psychosocial consequences of CAR T-cell therapy - a treatment option for some patients with non-Hodgkin lymphoma, acute lymphoblastic leukemia, and multiple myeloma.

At the conclusion of this course, participants will be able to:

Describe the rational for using HCT to treat patients with hematological disorders and certain genetic/immune system disorders, and the psychosocial issues associated with treatment in the short-and long-term.

Describe the steps involved in autologous HCT,andthe short- and long-term medical side effectsand psychosocial issues.

Describe the steps involved in an allogeneic HCT,and the short- and long-term medical side effects and psychosocial issues.

Describe how psychosocial issues associated with autologous HCT compareto those associated with an allogeneic HCT for both patients and care partners.

Explain what graft-versus-host disease (GVHD) is, differentiate acute vs chronic GVHD, describe the unique medical and psychosocial challenges that GHVD patients and care partnersexperience, and discuss psychotherapeutic treatment modalities to address those challenges.

Describe the incidence of and risk factors associated with common psychiatric disorders thatoccur during each phase of the HCT process and identify the psychiatric sequelae of common medications used to treat patients during HCT.

Describe the types of hematological disorders most frequently treated with CAR T-cell therapy and the unique stressors and medical and psychosocial sequelae that come with this treatment.

Describepsychological and psychiatric treatment modalities that have proven beneficial for these patient populations.

Amin M. Alousi MD

Professor of Medicine,Medical Director of theStem Cell Transplant and Cellular Therapy ProgramandDirector of the Multi-Discipline GVHD Clinic and Research Program,MD Anderson Cancer Center

Minoo Battiwalla, MD, MS

Director of Blood Cancer Outcomes Research,Sarah Cannon Transplant and Cellular Therapy Network

Michelle Bishop, PhD

Coping with Cancer & Caregiving, LLC Co-Director of Mental Health Projects andGVHD Support Group Program Lead, BMT InfoNet

R. Gregory Bociek, MD, MSc

Associate Professor, Oncology & Hematology,University of Nebraska Medical Center

Areej E-Jawahri, MD

Associate Professor of Medicine andDirector of the Bone Marrow Transplant Survivorship Program,Massachusetts General Hospital

Elizabeth M. Muenks, PhD

Assistant Professor,Psychiatry and Behavioral Sciences, andDirector of Psychology Services, University of Kansas Medical Center

Justin Regan, RN

Recipient of two allogeneic stem cell transplants

Maria Adelaida Rueda-Lara, MD

Assistant Professor, Department of Psychiatry & Behavioral Sciences andMedical Director of Psycho-Oncology,University of Miami Miller School of Medicine

John Wingard, MD

Professor of Medicine, Retired Deputy Director of theUF Health Cancer Center andDirector of the Bone Marrow Transplant Program,University of Florida Health Cancer Center

ENROLL in this course consisting of seven modules.Course fee - $199.(includes all seven modules)

COMPLETE COURSE CONTENT by finishing all modules.

TAKE THE POST-TEST assessment and achieve a passing grade of at least 75%

Complete the COURSE EVALUATION

Full attendance is required for all CE activities. This means you will be asked to certify that you watched all the videos included in this course.Once you have completed the above steps, your course certificate will automatically populate for download. It can be downloaded immediately, emailed, and will be available for future download.

Click to Enroll Now

There was no commercial support provided for this CE program, the content, or to the instructor(s).

It is absolutely critical that our program exemplifies accessibility for all participants. We seek to ensure all participants are able to fully, equally, and independently access the educational content. Our goal is to have a website that is perceivable, operable, understandable, and robust. If you have any difficulty navigating the website, we want to know! Please contact us atinfo@findempathy.com.

CE credits require a post-test assessment. The assessment is untimed and provided in writing on the course website. However, for individuals with visual impairments, or those that may benefit from an orally presented post-test and program evaluation, contact us. We will work with you to find an alternative option for completing the course post-test and program evaluation.We remain available and open to ANY additional requests for format modification or additional assistance.

If any accommodations are needed to enroll or participate in the course, or complete the post-test and course evaluation, please contact us atinfo@findempathy.com.

Course Access::Once enrolled in a course, you have 30 days to complete the post-test and course evaluation. If your access lapses before completing all tasks, you may need to re-enroll.

Certificate Access: Once you have completed the post-test and program evaluation, your certificate will be immediately available for download. Find Empathy will keep course certificates on file for 7 years. If a certificate is needed log into your Find Empathy account and download it, or contact:info@findempathy.com.

Post-test Retake Policy:You are allotted 3 retries to achieve the acceptable 75% passing grade.

This course is intended for psychologists, social workers, mental health counselors, and therapists. The instructional level is intermediate. We assume that participants already have psycho-oncology educational background and experience. The primary format is a non-interactive distance-learning continuing education course presented through a series of videos. There was no commercial support provided for this CE program, the content, or to the instructor(s).

Contact us atinfo@findempathy.com. We will do our best to return your email within 24-48 hours during business hours: Monday through Friday, 9am to 5pm eastern.If you have any questions, concerns, or grievances please email us atinfo@findempathy.com.You can also see our grievance policy via the following link:findempathy.com/grievance.

PSYCHOLOGISTS

Empathie, LLC is approved by the American Psychological Association to sponsor continuing education for psychologists. Empathie, LLC maintains responsibility for this program and its content.

COUNSELORS: Find Empathy has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 7257. Programs that do not qualify for NBCC credit are clearly identified. Find Empathy is solely responsible for all aspects of the program

SOCIAL WORKERS

Find Empathy, #1817, is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved as ACE providers. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. Find Empathy maintains responsibility for this course. ACE provider approval period: 5/14/2023-5/14/2026. Social workers completing this course receive 7 continuing education credits.

Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience,[course number],is approved by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program to be offered by Find Empathy as an individual course. Individual courses, not providers, are approved at the course level. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit.ACE course approval period: [dates]. Social workers completing this course receive 7 continuing education credits.

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Stem Cell Transplant and CAR T-cell Therapy: The Patient and Care Partner Experience | BMT Infonet - BMT Infonet |

BioRestorative Therapies to Present Preliminary BRTX-100 Clinical Data at the Orthopaedic Research Society (ORS … – OrthoSpineNews

Blinded data from the ongoing Phase 2 clinical trial of BRTX-100 to be described in poster presentation

Company to host webcasted conference call to review data on February 5, 2024 at 8:30am EST

MELVILLE, N.Y., Feb. 01, 2024 (GLOBE NEWSWIRE) BioRestorative Therapies, Inc. (BioRestorative, BRTX or the Company) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that preliminary 2652 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease (cLDD) will be presented by Francisco Silva, Vice President of Research and Development, at the Orthopaedic Research Society (ORS) 2024 Annual Meeting, taking place February 2-6, 2024 in Long Beach, California.

BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Companys lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo.

The presentation, titled Autologous Stem Cell Therapy for Chronic Lumbar Disc Disease, Initial Phase 2 Clinical Safety and Feasibility Data of Intradiscal Injections of Hypoxic Cultured Mesenchymal Stem Cells, is scheduled for Sunday, February 4, 2024 between 10:15am-11:15am PST.

We are excited by this opportunity to share, for the very first time, preliminary data from the ongoing Phase 2 clinical trial of BRTX-100 in the treatment of cLDD, said Lance Alstodt, Chief Executive Officer of BioRestorative. As interest in the potential clinical benefits of BRTX-100 grows, it is important that we continue to drive awareness of this novel therapeutic candidate amongst researchers, regulators and clinicians through clinical presentations at important meetings like ORS.

Conference Call & Webcast Details

BioRestorative management will host a webcasted conference call with an associated slide presentation at 8:30am EST on Monday, February 5, 2024 to review the BRTX-100 poster. To join the conference call via phone and participate in the live Q&A session, please dial 888-506-0062 (United States) or 973-528-0011 (International), participant access code 234972. The live webcast and audio archive of the presentation may be accessed on the investor section of the BioRestorative website athttps://www.biorestorative.com/investor-relations/. An archived replay will be available for approximately 90 days following the event.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate,BRTX-100,is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. TheBRTX-100production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure,BRTX-100is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial usingBRTX-100to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Companys latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT: Email:ir@biorestorative.com

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BioRestorative Therapies to Present Preliminary BRTX-100 Clinical Data at the Orthopaedic Research Society (ORS ... - OrthoSpineNews

New FDA-approved sickle cell gene editing therapies offer hope for a pain-free life to patients some living in Colorado – Colorado Public Radio

Growing up, I really didnt have as many crises with sickle cell, Hymes said in a recent virtual interview from Arkansas. When I was getting older, I started having more and more sickle cell crises. But Ive always had this dream of becoming a physician, and as I got older, the more crises I had, the harder it made that journey.

A report from the Centers for Disease Control and Prevention (CDC) stated the origins of the pain: Sickled cells traveling through small blood vessels can get stuck and block blood flow throughout the body, causing pain. A pain crisis (vaso-occlusive episode or VOE) can start suddenly, be mild to severe, and can last for any length of time.

If you got hit by a bus and survived, all that excruciating pain that you would feel, thats how Id describe it. Id spend a week, two weeks, in the hospital, and then you have to recover, thats another week, and Id miss two weeks of class, Hymes said when explaining what living through a pain crisis has been like for him.

So, he looked for a solution by doing some online research that led him to McKinneys work.

We shot a few emails back and forth and it just felt like the right place to be I knew that the life I wanted and how it was going couldnt really co-exist, he said. Leading up to around the time I reached out to Dr. McKinney, I started to have crises almost every other month or sometimes even every month.

After he and McKinney developed an email relationship, Hymes came to Colorado for some blood work and testing and discovered he was a match for the trial.

Once it was determined that I could, I became a little more hopeful in the journey, said Hymes, who didnt dwell on the challenges of that journey, and instead honored the people who helped him through it: his mother, his girlfriend, and his grandparents all of whom came to visit him in Colorado, while he spent months coping with the complicated procedure.

We evaluate the patient to ensure their organs are healthy enough to tolerate the gene therapy process; we then start putting them on chronic transfusions where they get a monthly transfusion to decrease how much sickle hemoglobin they have," explained McKinney. "We give them medications to help them release their stem cells from their bone marrow into their blood and we hook them up to machines to collect those stem cells.

Its those cells that then get the gene therapy, they are edited to stop forming the sickle shape.

And that may take several months to get enough stem cells ... once weve collected those stem cells, we have to send those stem cells off to manufacture and to change the genes so that they make non-sickling hemoglobin. And that process can take about 12 weeks, McKinney said.

Patients then return for high doses of chemotherapy, which gets rid of the old bone marrow and makes room for the new.

Once they get that chemotherapy, we then infuse the stem cells, and it can take about four weeks for those cells to grow, McKinney said. The patient remains in the hospital while the new stem cells grow. Upon discharge, they have years of follow-up monitoring. Ultimately, patients who receive gene therapy need to be followed for about 15 years after the infusion to make sure theyre doing well."

For Hymes, things went according to plan. Because he was from out of town, he had to stay in Colorado for about six months in total. He said part of it was to have my edited genes put back in my body, and thats when I would have the chemo and stay in the hospital for an extended period of time.

Recovering from the chemotherapy, Hymes said, was one of the hardest parts.

I was still having to deal with the chemo and all the problems that it can cause. Its just this really bad taste you could have from the chemo and it could knock out your taste and you have a sore throat ... I guess Im a big eater, so food was the important part to me. But I drank a lot of Ensures just recovering from the chemo, said Hymes.

Now, two years since his journey began and one year after the transplant, Hymes said he feels like a new man.

It was a total change in my energy level and how I was able to just go about life! I didnt have to worry about having pain crises every other day or every month, said Hymes.

Regarding his pain crisis, Hymes said, Its almost non-existent at this point. I dont say almost non-existent. Its been non-existent at this point.

Like about 90 percent of McKinneys other trial participants, its all over now.

I havent had any crises since I had the stem cell transplant, and sickle cell-related problems since the transplant. So I would say it has been extremely beneficial in my life, said Hymes.He said it's also been good for his mother.

I only seen my mom cry one or two times, Hymes explained. One time was seeing him struggle with the disease, the other time, Hymes said, was seeing him leave it behind.

The two FDA-approved treatments are slightly different from what Hymes received but they work the same way, editing cells, and then returning them to the patient.

Now that the drug therapy has been approved, another component of McKinneys job is to let the rest of his patients the ones who werent part of a trial know about it. Some of those who werent in any of his trials experience pain from the disease serious enough to make the therapy worth considering.

A few weeks after the FDA announced its approval of the drugs in early December, McKinney met with Mia Hilton, a 20-year-old esthetician from Green Valley Ranch in Denver. Hilton has been McKinneys patient for the past 10 years. Vivacious and upbeat, she spent most of the meeting making funny comments. After a quick overall exam, he asked if shed heard about the newly approved gene therapies.

They are meant to be curative, he explained. Youd no longer have sickle cell after administration of them.

For her, that would be a big change. Like Hymes, sometimes, her pain got bad enough to go to the ER, where shed sometimes receive intravenous drugs.

Usually a pain crisis feels kind of like burning or stabbing a little bit. It can feel pretty hot internally in your muscles. I'll take a Benadryl and then they'll give me morphine through my IV, and that usually works, said Hilton. If not, she gets a nasal dose of fentanyl. In the ER, medical staff monitor her progress.

They usually do a chest X-ray to make sure that I'm not going to have a chest crisis, explained Hilton. And after a few hours, if the pain was under control, shed get discharged. I'll have somebody come and pick me up from the ER just because of the heavy medicines, they don't want me to drive.

Sometimes, when she didnt bounce back, she would be admitted from the ER into the hospital.

Usually my stay can range from three to seven days, so it does get pretty strenuous, she said.

She told McKinney that shed heard some pieces of information about the new gene therapies, but wanted to know more. In a cautious, gentle voice, he told her, The side effects of the chemo could cause infertility and hair loss.

Hilton had a quick answer to that.

Ive never wanted babies, she said, So its a free form of birth control.

I'm very into make-up and hair, so I already have 40 wigs in my closet, the bubbly woman added while already wearing eyelashes nearly an inch long. When McKinney mentioned that painful sores could form in her mouth, she didnt care about that either.

I bite my jaws a lot, so Im already there. I bit my tongue and my jaw four times in the elevator on the way up here, said Hilton.

Her reservations focused on the time shed lose working, and concerns about whether her case was severe enough to warrant the sacrifice.

I love science, so to hear that you're going to take something out, fix it, and put it back, it's like, Oh my gosh, that's kind of cool. Personally, I would definitely look into it, but ... I don't know if I would have the energy to do that. You know what I mean? I would be pretty much down to do it because I feel like in the long run, it could really help because having sickle cell, if you're not on top of it and you're not maintaining it, it can really slow you down ... So to get rid of crises altogether, that would be pretty ideal, said Hilton.

Although the side effects didnt bother Hilton, the cost could if her insurance wont cover it. One therapy costs $2 million, and the other is $3 million. But, according to Dr. David Rind, chief medical officer at the Institute for Clinical and Economic Review, a nonprofit that evaluates the prices and effectiveness of medications, that price wouldnt come out of the patients pocket. He said he expects insurance companies to cover the gene therapy.

I dont think any manufacturer would charge a price like that thinking only the patients who can afford it will get it, Rind said. I think the assumption is that insurance will pay for this ... I think this will be paid for, for almost anyone who wants it.

The rationale for why insurers should cover the gene therapies relates to slavery, he said.

The reason there is sickle cell in the U.S. is because we brought Africans over as slaves, Rind said. He explained that the disease is a gene mutation that fights malaria, a disease common in Africa. Thats why the people who are here have sickle cell . This is a population obligation in the United States to get this right.

Hymes has a sense of obligation, too, to other people born, like him, with the disease. Now that he has gotten rid of his crises as a clinical trial participant, what he thinks would be ideal is to become a doctor caring for people with sickle cell.

My entire life, Ive been extremely interested in hematology-oncology, of course, because that is what [sickle cell disease] is grouped as. But lately, Ive been interested in emergency medicine as well, because I know a lot of times we get seen on the front end in the emergency room, and thats where a lot of chronic pain patients get perceived as opioid-seeking, said Hymes.

He is now participating in an academic program for aspiring medical students while waiting to hear if hes been accepted to medical school. Once he has completed his medical degree, he said, he knows hed have the sensitivity to understand a sickle cell disease patients experience as real, not one of faking pain in the ER.

So either helping on that side or helping in the hematology and oncology area is what Im interested in. If I could do both or figure out a way to help all across the board, then Id probably choose that, too, said Hymes.

McKinney looks forward to offering his patients the choice of a different ending.

Now, when those families come in for their first visit with us to talk about what its going to look like for their child to live with sickle cell disease, we can at least provide them some hope that this is something that is very, very treatable, McKinney said. Something that if theyre having a lot of problems related to this, that we can potentially cure and get rid of.

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New FDA-approved sickle cell gene editing therapies offer hope for a pain-free life to patients some living in Colorado - Colorado Public Radio