Category Archives: Cell Therapy

Celyad has received Fast Track Designation from the FDA for C-Cure, a cell therapy aimed to treat heart failure with the patients own stem cells.

Celyad is confident that the announcement of Fast Track Designation from the FDA will help it accelerate the search for a partner to develop C-Cure, a cell therapy for ischemic heart failure. After running a Phase III trial in Europe that didnt meet its primary endpoint, the Belgian biotech identified a subpopulation of more of 60% of patients that did show a significant improvement and is now determined to try again once it finds financial support.

CelyadsC-Cure technology consists in the harvest of the patients bone marrow, which is treated with growth factors and then re-injected into the heart to grow new functional muscle in the area lost due to infarction. The therapy is complementary to Celyads main focus, immuno-oncology. The company is well-known for developing an allogeneic version of the promising CAR-T technologythat recently triggered a license agreement with Novartis.

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May 09, 2017 04:49 ET | Source: Research and Markets

Dublin, May 09, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global CAR T Cell Therapy Market & Clinical Trials Insight 2022" report to their offering.

Global CAR T Cell Therapy Market & Clinical Trials Insight 2022 report highlights the ongoing clinical and non-clinical advancement in the field of Car T Cell Therapy.

As per report findings, the promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients. Currently, there are 99 CAR T Cell based therapies in clinical pipeline and most of them belong to Phase-I and Phase-I/II clinical trials.

In recent years, researchers have identified the chimeric antigen receptor as a potential target for molecular genetics to insert a new epitopes on the receptor region which allows a degree of control of the immune system. CAR T cell therapy satisfy the need to explore new and efficacious adoptive T cell therapy. The gene transfer technology could efficiently introduce the genes encoding CARs into the immune effector cells. The transferring of engineered T cells provides the specific antigen binding in a non-major histocompatibility complex.

The promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients.

The first commercial application of CAR T Cell based therapy for the treatment of Mantle- Non-Hodgkin's lymphoma is expected to be available from 2020. The anti-CD19 CAR T cell therapy axicabtagene ciloleucel (KTE-C19) is developed by KITE Pharma in collaboration with National Cancer Institute. Currently this therapy is in preregistration phase.

In future, the advancement of CAR T Cell therapy will be largely driven by academia and will require the support for the expensive early phase clinical trials which promise to cover the way for a new form of targeted, exportable immunotherapy for cancer patient. The manufacturing of CD19 CAR T cell therapy CTL019 is in a way which will modernize the process of using the therapy globally. The anticipation of regulatory and manufacturing issues before they arise and proactively addressing the concerns helps to accelerate the process of bringing this promising therapeutic approach to more patients in future.

Global CAR T Cell Therapy Market & Clinical Trials Insight 2022 report highlights:

- CAR T Cell Therapies Delivery Pipeline & Mechanism of Action - Global CAR T Cell Therapy Clinical Trials for Cancer Treatment - Global CAR T Cell Therapies Clinical Pipeline by Company, Indication & Phase - Global CAR T Cell Therapies Clinical Pipeline: 99 Therapies - CAR T Cell Therapies in Highest Phase: Preregistration - Majority of CAR T Cell Therapies in Phase-I/II Trials: 16 Therapies - Global Market Scenario of CAR T Cell Therapy - Global CAR T Cell Therapy Market Future Prospects

Key Topics Covered:

1. Chimeric Antigen Receptor (CAR) T Cell Therapy - Next Era in Immuno Oncology 1.1 Overview 1.2 History & Development of CAR-T Technology

2. Evolution of Chimeric Antigen Receptor (CAR) T-Cell Design 2.1 Structure of CAR T Cell 2.2 1nd Generation Chimeric Antigen Receptor 2.3 2nd & 3nd Generation CAR T Cell

3. Principle of Chimeric Antigen Receptor Design 3.1 CAR Modified T Cells: Targeting 3.2 CAR Modified T Cell: Signaling

4. CAR T Cell Therapies Delivery Pipeline & Mechanism of Action 4.1 Process of CAR T Cell Therapy 4.2 Mechanism of Action

5. Approaches to Improve the CAR T Cell Therapy 5.1 Introduction 5.2 Targeting the Tumor Stroma with CAR T Cells 5.3 Targeting the Cytokine Networks 5.4 Combination Strategies for CAR T Cells 5.5 Targeting the Immune Checkpoints

6. Global CAR T Cell Therapy Clinical Trials for Cancer Treatment 6.1 Acute Lymphoblastic Leukemia 6.2 Multiple Myeloma 6.3 Brain Tumors 6.4 Lymphoma 6.5 Solid Tumors

7. Global CAR T Cell Therapies Clinical Pipeline by Company, Indication & Phase 7.1 Research 7.2 Preclinical 7.3 Clinical 7.4 Phase-I 7.5 Phase-I/II 7.6 Phase-II 7.7 Preregistration

8. Global Market Scenario of CAR T Cell Therapy 8.1 Overview 8.2 Estimated Price Analysis of CAR T Cell Therapy

9. Global Market Size of CAR T Cell Therapy 9.1 Market Share of Cancer Immunotherapy by its Technology 9.2 CAR T Cell Therapy Market Value

10. Global CAR T Cell Therapy Market Dynamics 10.1 Favorable Parameters 10.2 Challenges

11. Global CAR T Cell Therapy Market Future Prospects

12. Competitive Landscape 12.1 Autolus 12.2 Bellicum 12.3 Bluebird 12.4 Celgene 12.5 Cellectis 12.6 Celyad 12.7 Eureka Therapeutics 12.8 Fortress Biotech 12.9 Immune Therapeutics 12.10 Juno Therapeutics 12.11 Kite Pharma 12.12 Novartis 12.13 Sorrento therapeutics 12.14 TILT Biotherapeutics 12.15 Ziopharm

For more information about this report visit http://www.researchandmarkets.com/research/6tj28w/global_car_t_cell

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Global CAR T Cell Therapy Market & Clinical Trials Insight 2017-2022: Clinical Pipeline of 99 Therapies - GlobeNewswire (press release)

The Indy 500 legend has been through several highs and lows recently. Clark Wade/IndyStar

Indianapolis 500 legend A.J. Foyt.(Photo: Clark Wade/IndyStar)Buy Photo

Its been a long and wild ride, and A.J. Foyt has enjoyed nearly every second of it.

I had a lot of fun, the 82-year-old racing legend told IndyStar on Wednesday at his racing garage in Speedway. If I passed out talking to you right now and fell on the floor, at least I made good money, had a happy life and what else can you ask for? So many people are so miserable with their jobs and that. I had a wonderful job doing what was fun.

Foyts job driving into racing's history books provided him with a lifetimes worth of close friends, amazing stories and thrilling adventures. But it also often required him to put his life on the line.

"I guess I was a little bit crazy back in those days,"Foyt, who walks with a limp but without assistance, said with a smile.

But being crazy was part of the job, he said. He needed it to overcome his fears.

"A lot of race drivers you talk to these days say they've never been scared in racing," Foyt said. "Well, they're lying to you and they're lying to themselves. I cannot name you one race at one time or another thatI didn'tscare the hellout of myself. Honestly. I don't know if that's good or bad, but I'm just being honest with you."

Read more from Jim: Alexander Rossi is starting to feel at home in Indy

This year's Indy 500 crowd is on pace to pass 300,000

Despite thosehealthy fears, his long and prestigious racing career resulted ina laundry list of injuries and eventual ailments that would and have horrifieddoctors.

The four-time Indianapolis 500 champion has stared death and dismemberment in the face more times than hed care to count, dealing withcar wrecks, killer bees, a bulldozer accident, heart ailments and two staph infections. As a result, hes nearly had his feet amputated,broken his back two or three times, has two false knees and a false hip, a titanium plate in his chest from open heart surgeryand said hell be on antibiotics for the rest of his life because of the amount of metal he has inside of him.

But he's far from discouraged and fightsto keep going with the same vigor and courage the colored his youth. One way he's done so recently is by undergoing stem cell therapy.Foyt said his wife, Lucy, who suffers from diabetes and arthritis, suggested that they both take on the treatment in order to try and find "the fountain of youth."

I mainly did it for her, Foyt said. She got sugar diabetes real bad, and (is) pretty sick, but, of course, I did it for myself too, dont get me wrong. But shes really been suffering the last five or six years. So we just thought wed try it.

A.J. and Lucy Foyt spent seven days in Cancun, Mexico the treatment is not performed in the United States undergoing a therapy he said likely wont take effect for another month at least. A.J. Foyt had adult stem cells injected into each shoulder and ankle, as well as into his blood.

Theres no guarantees the treatment will help either of them, but the uncertainty doesnt bother him.

I figure if we gain something, fine, and if we dont, well, Ive lost before," Foyt said.

But giving Foyt an edge in his fight against injury, ailment and Father Timeis a competitive fire that has burned within him his whole life.

A little more than a month ago, Foyt and fellow driving legend Dan Gurney were honored in Long Beach, Calif., for the 50th anniversary of their all-American victory at 24 Hours of Le Mans. Many racing greats attended the event, and Foyt was happy to see them, but he couldn't help but stackhimself up one more time against his old rivals.

I guess Im doing better than them, Foyt said with a smile. Poor Parnelli (Jones) has a lot of back trouble. Dan was in a wheelchair. Last three or four years Ive been going in and out of them, but Im still going pretty strong. So far Im hanging in there pretty good. ...Every days a good day. And Iguess thats good when youre getting ready to kick."

Follow IndyStar Motor Sports Insider Jim Ayello on Twitter and Instagram: @jimayello.

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Title: Long-term follow-up data from 126 patients with recurrent high grade glioma from three Phase 1 trials of Toca 511 and Toca FC: Update and justification for a Phase 2/3 trial Presentation Type: Podium Session: Immunotherapy Clinical Trials for Cancer Presenter: Douglas Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen Summary: As previously presented, data from three Phase 1 trials of Toca 511 and Toca FC in 126 patients with recurrent high grade glioma demonstrate potential benefits, including durable objective responses, extended overall survival and a favorable safety profile.

Title: TOCA 511 & 5-FC: Anti-tumor activity, immune memory and prolonged survival even at low infection levels Presentation Type: Poster Session: Cancer-Immunotherapy, Cancer Vaccines I Presenter: Kader Yagiz, Ph.D., research scientist at Tocagen Summary: Data from preclinical models suggest that even a small percentage of Toca 511 infection results in anti-tumor immune activation and a significant increase in survival following 5-FC treatment.

About Tocagen

Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen is developing its lead investigational product candidate, Toca 511 & Toca FC, initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Toca 511 & Toca FC was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent HGG. Tocagen has received grant support from leading brain cancer foundations, includingAccelerate Brain Cancer Cure(ABC2),National Brain Tumor Society(NBTS), American Brain Tumor Association (ABTA),Musella FoundationandVoices Against Brain Cancer (VABC).

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/tocagen-presents-data-at-the-american-society-of-gene-and-cell-therapy-20th-annual-meeting-300455756.html

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Tocagen Presents Data at the American Society of Gene and Cell Therapy 20th Annual Meeting - PR Newswire (press release)

It is increasingly important that oncology nurses and other healthcare providers recognize cytokine release syndrome (CRS) and other side effects that can be triggered by anticancer treatment with engineered chimeric antigen receptor (CAR) T-cell therapies, and that they understand the importance of early detection, a speaker emphasized at the Oncology Nursing Society (ONS) 42nd Annual Congress, held May 47 in Denver.

Careful monitoring is essential for early detection of CAR T-cell side effects, said study coauthor Brenna Hansen, BSN, RN, OCN, a research nurse specialist at the Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. Early recognition of symptoms results in early intervention and safe management of the patient by the multidisciplinary team.

CAR T-cell therapy involves equipping immune T cells with engineered receptors to facilitate immune attack on tumor cells expressing specific surface proteins. Patient T cells are collected and modified in a lab to express cancer-specific receptors. These are then infused back into the patient.

CAR T-cell therapies show promise against hematologic malignancies and other cancers but can trigger a range of initially subtle but potentially life-threatening side effects. Perhaps chief among these adverse reactions is CRS and neurologic side effects that might or might not occur with CRS. Most of these are reversible with corticosteroids or other treatment.

CRS symptoms include fever, tachycardia, and hypotension occurring within a week (typically 47 days) after CAR T-cell infusion, though CRS can occur more quickly. Ive seen CRS as soon as a day after infusion, Hansen cautioned.

Heart arrhythmias, fatigue, hypoxia, pulmonary edema, pneumonitis, electrolyte imbalances, nausea, vomiting, diarrhea, cytopenias, infections, elevated creatinine kinase, myalgia, and muscle weakness can all be signs of CRS.

Neurologic side effects can include tremors, headaches, confusion, loss of balance, trouble speaking, encephalopathy, seizures, long periods of somnolence, and sometimes, hallucinations, Hansen noted.

These symptoms can be subtle initially. Hansen described a CAR T-cell therapy patients transportation by ambulance to the hospital after detection of a subtle hand tremor because clinicians were concerned it could quickly worsen.

CAR T-cell therapies can also trigger receptor/cell-type specific side effects such as CAR19-associated B-cell aplasia and graft-vs-host disease. New side effects will likely emerge as new targets are found and CAR T-cell therapies become more commonly administered, she predicted.

Nurses play key roles in every stage of CAR T-cell toxicity monitoring and management, from inpatient monitoring at the bedside, including frequent assessments and checks of vital signs during high-risk periods, to outpatient and long-term monitoring, Hansen said.

Outpatient monitoring for patients who are infused as outpatients, or post-discharge, is key to spotting delayed toxicities, she emphasized. Clinic and triage nurses play key roles in the timely recognition of late CAR T-cell side effects.

Long-term monitoring is important, as well. Home oncology clinic nurses should monitor serum IgG (IVIG) and blood cell counts with differential.

If symptoms become severe, cells may be tempered with tocilizumab or corticosteroids, she said. However, this is avoided if possible to prevent damaging the anti-malignancy effects of the CAR T cells.

It is crucial that nursing staff be educated on side effects unique to CAR T-cell treatments, and that nursing guidance be provided specifying the signs and symptoms that should be communicated to patients other healthcare providersand patients themselvesto allow early detection and intervention. Having a written plan can help prevent confusion and provide clear guidelines for the patients care, she noted.

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Oncology Nurses Must Watch for CAR T-Cell Therapy Side Effects - Cancer Network

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Phase 1 Trial of CAR-T Cell Therapy for Head and Neck Cancer Cancer Therapy Advisor Description: For this single-arm, phase 1 study (ClinicalTrials.gov Identifier: NCT01818323), researchers are evaluating whether patients with squamous cell cancer of the head and neck will respond to autologous T4+ positive T cells administered ...

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Phase 1 Trial of CAR-T Cell Therapy for Head and Neck Cancer - Cancer Therapy Advisor

May 9, 2017 Credit: Vetsuisse Faculty, UZH

The intervertebral disc is the "shock absorber" between the vertebrae of the spine, cushioning every step, bend and jump. If the fibrocartilage tissue in the spine degenerates over time, an intervertebral disc can "slip" pinching the medulla or nerves. The consequences include intense pain or even paralysis. Dogs and people are often susceptible to this disease. Since intervertebral discs themselves cannot regenerate, the affected disc material is removed in an operation that can be performed on both people and animals. The pressure on the nerves and medulla disappears, but the degeneration of the disc remains.

Frank Steffen, neurologist at the Clinic for Small Animal Surgery at the Vetsuisse Faculty of the University of Zurich, has developed a stem cell therapy for the condition. Stem cells are multipotent cells that can be differentiated into various cell types. Steffen hopes that the stem cells will possibly form new disc cartilage once injected into a damaged disc. His study on three sick German shepherds demonstrate that treatment with the body's own stem cells is well tolerated an important first step.

Gaining knowledge directly from the afflicted animal

Research on intervertebral disc regeneration is frequently performed using animal testing. At the Clinic for Small Animal Surgery in Zurich, researchers have taken another path: "Since we treat numerous dogs who spontaneously sustain a slipped disc every year, we have been able to gain important knowledge directly from animals that are actually afflicted with this disease," Steffen explains. "Due to the similarity in pathology and the course of the illness, conclusions can presumably be drawn for the treatment of affected persons as well." The project for the development of stem cell therapy in dogs is being conducted in cooperation with Swiss Paraplegic Research (SPR) in Nottwil, Switzerland.

With the permission of the dog owners, Steffen and his team removed stem cells from the marrow of the pelvic bone of the affected animals. After the cleaning and preparation of the cell material in the laboratory, the stem cells were injected into the degenerated intervertebral disc during an operation. "Our objective is for the stem cells to trigger cellular and molecular repair processes and, ideally, to form new intervertebral disc cells in order to contribute to the regeneration of the tissue," Steffen says.

After tolerability, check effectiveness

The results are promising: The three dogs tolerated the injections of their own stem cells and the researchers have determined no negative effects. However, later X-rays and magnetic resonance tomographies did not show clear indications that the damaged discs have regenerated in comparison with the control group.

Steffen says, "Proving the tolerability of the therapy was our first important step." Now, he is working on the effectiveness of the stem cell injections with the targeted addition of growth factors. "If our method proves successful one day, it would be a pioneering step for human medicine as well," the neurologist says.

Explore further: MRI can visualize effects of traction on herniated discs

More information: Frank Steffen et al. Bone Marrow-Derived Mesenchymal Stem Cells as Autologous Therapy in Dogs with Naturally Occurring Intervertebral Disc Disease: Feasibility, Safety and Preliminary Results, Tissue Engineering Part C: Methods (2017). DOI: 10.1089/ten.TEC.2017.0033

Certain blood vessels in the brainstem constrict when blood vessels elsewhere in the body would dilate. And that contrary behavior is what keeps us breathing, according to a new paper by UConn researchers published May 8 ...

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Stem cells therapy for naturally occurring intervertebral disc disease - Medical Xpress

Platelets, small fragments of large cells that are a very abundant component of blood, and best known for their role in blood-clotting, help hide cancer from the immune system by suppressing T cells, according to a new study.

Now, in preclinical studies, researchers led by Zihai Li, M.D. Ph.D., chair of the Medical University of South Carolinas Department of Microbiology and Immunology found adoptive T cell therapy was more effective against melanoma when combined with common platelet-inhibitors, such as aspirin.

A disorder known as thrombocytosis, where a patient has excess platelet product, has been associated with the progression of multiple cancer types. However, how platelets change T cell immunity to encourage tumor growth was not well understood and this study sought to investigate the role more closely.

A molecule called TGF-beta is linked to suppression of the cancer-fighting activity of T cells, the study found. Immunologists have been studying TGF-beta for more than 30 years as it regulates many aspects of the immune system.

More importantly, Lis team found a protein called GARP, on the surface of the platelets, acts like a molecular hook that binds to and activates TGF-beta.

We found for the first time that the GARP, TGF-beta complex is a key mechanism utilized by platelets to subvert T cell immunity, Li said.

The first indication that the bodys clotting system might play a role in suppressing cancer-fighting T cells, was when scientists observed melanoma mouse models with genetically defective platelets.

In the mice with genetically defective platelets, T cells that were isolated and then primed to recognize tumor cells were much more active when reinjected into the mice, and tumors grew significantly more slowly than in animals with normal platelets.

Platelets and T cells isolated from mouse and human blood were observed, and both showed the T cell response was suppressed by platelets with activated clotting activity. Using mass spectrometry, the team identified the molecule with the most T cell suppression was TGF-beta.

Next, Li investigated what would happen if the platelets couldnt activate TGF-beta. They genetically modified mice without the molecular hook GARP, and found that once the platelets didnt have the ability to grab and activate TGF-beta, they could not suppress the cancer-fighting T cells. The T cell immunotherapy was more effective at controlling melanoma.

In a final experiment, the team tested melanoma models of mice with normal platelets who received adoptive T cell therapy, in combination with two antiplatelet drugs, aspirin and clopidogrel. They found that animals who received the antiplatelet drugs survived longer and relapsed less.

One popular form of current immunotherapy is so-called checkpoint inhibitors. Li and his team are about to launch a clinical trial to test the combination of checkpoint inhibitors and aspirin and clopidogrel for advanced cancers.

Im very excited about this, Li said. We can test simple, over-the-counter antiplatelet agents to really improve immunity and make a difference in how to treat people with cancer.

The findings were published May 5 in Science Immunology.

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Antiplatelet Drugs Could Boost Effectiveness of Adoptive T Cell Therapy - Bioscience Technology

Engineered T-cell therapies, a promising way to prime a patients immune system against cancer, dont work for everyone. Scientists from the Medical University of South Carolina (MUSC)found one possible explanation that can be targeted: blood platelets.

The immune system sees tumors, or uncontrolled cell growth, as part of the self, which allows cancer to evade immune attack. In adoptive T-cell therapy, a patients own T cells are isolated from his or her blood, and then primed to recognize tumor cells.

Previous research has shown that some cancers curb T-cell activity and that platelets, a component of blood responsible for clotting, might make cancer worse. The MUSC team, led by senior author Zihai Li, M.D., Ph.D.,found that platelets help cancer to hide by secreting a molecule, TGF-beta, that suppresses T cells.

RELATED: New culture method boosts T cells' ability to recognize multiple cancers

While most TGF-beta is inactive, the researchers found that GARP, a molecular hook on the surface of platelets, traps and activates TGF-beta. As a result, platelets become the main source of TGF-beta used by tumor cells to tamp down on T-cell function, according to a statement.

The team ran a battery of preclinical trials, finding that a T-cell therapy more effectively awoke the immune system when given alongside common antiplatelet drugs, such as aspirin.

First, they noticed that melanoma tumors grew more slowly in mice with defective platelets than in mice with normal platelets. Adoptive T-cell therapy was more effective in genetically modified mice without GARP. And mice with normal platelets and melanoma that were given T-cell therapy along with aspirin and clopidogrelsurvived longer and relapsed less, according to the statement. But antiplatelet drugs alone did not fight the cancer.

"We can test simple, over-the-counter antiplatelet agents to really improve immunity and make a difference in how to treat people with cancer, Li said. The study was published in Nature Immunology.

This study could lay the foundation for further work testing antiplatelet approaches in melanoma and other cancers. Melanoma is not currently treated with adoptive T-cell therapy, but with checkpoint inhibitors, such as Bristol-Myers Opdivo and Yervoy.

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Former Tranmere Rovers player Joe Thompson has shared an inspiring photo as he begins stem cell therapy to battle his cancer.

The 28-year-old is battling the disease for the second time, after first discovering tumours in his neck in 2013.

The footballer played 32 games for Rovers in 2012 and 2013, before being diagnosed with nodular sclerosing Hodgkins disease.

He fought through six months of chemotherapy before returning to football, joining Bury and then starting at Rochdale last summer.

Now Joe has shared a brave photo from hospital, as he undergoes stem cell therapy.

Posting the picture to Twitter he said: Little Update, First day of the Stem Cell Harvest Process! Docs are very surprised with how good my blood counts are! Hearts super fit.

When he first announced his cancer had resturned in March Joe said his wife and daughter were his daily motivation.

He said: I will fight this life hurdle with the same belief, courage and desire as my previous battle.

The support shown to me since I discovered my illness has returned has been immense.

I would like to thank my wife, Chantelle, who was my rock in my first encounter and will once again be by my side with the same encouragement, discipline and strength.

Not to mention the love shown to me by both my wife and beautiful daughter Thailula-Lily who are both my motivations daily.

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Former Tranmere footballer shares powerful picture as he begins fighting cancer with stem cell therapy - Liverpool Echo