Cell and Gene Therapy Clinical Trials

Leading the Way in Stem Cell Clinical Trials and Gene Therapy Clinical Trials

Gene therapy and Stem cells clinical trials represent a significant frontier in medical research, offering the potential to treat and even cure diseases that were once thought to be untreatable. At Navitas Life Sciences, we leverage over three decades of experience in clinical stem cell trials to advance stem cell therapy across various therapeutic indications, including stroke, cerebral palsy, osteoarthritis, and diabetic foot ulcers. Our team has conducted 12 end-to-end studies involving more than 1,200 patients across 80 sites globally, with sponsors ranging from private entities to government bodies in the US, Germany, Malaysia, and Israel.

Seamless Solutions for Cell and Gene Therapy Clinical Trial Success

Our approach to clinical trials with stem cells is rooted in providing end-to-end solutions, integrating laboratory services, ultra-cold chain logistics, and trial management to streamline the development process. This seamless integration reduces the burden of vendor management and ensures continuity and efficiency throughout the clinical stem cell trial lifecycle. Powering possibilities in stem cell clinical trials and gene therapy clinical trials, Navitas Life Sciences is committed to delivering cutting-edge therapies to those in need, offering hope for improved health outcomes and quality of life.

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Our Advanced solution for cell and Gene Therapy

Reputation
Reputation
The Department of Biotechnology, Government of India, selected Navitas Life Sciences as the CRO to monitor three trials and generate data acceptable to global regulators.
Niche Global experience in stem cell therapy
Niche Global experience in stem cell therapy
In a Phase II rescue trial for a US sponsor, we worked with Indian regulators, ICMR, and DCGI, contributing to draft guideline development. Other studies addressed safety concerns by forming a Data Safety Monitoring Board (DSMB) and secured approval for stroke stem cell therapy under Malaysian regulations.
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Structured monitoring and expertise for LTFU of upto 15 years for delayed side effects and treatment durability through biomarker assessments, active AE reporting, and PROs. Special emphasis on insertional mutagenesis, secondary cancers years, chronic GVHD, and long-term tissue toxicity affecting organ function, and persistent immune responses.
Reputation
Reputation
The Department of Biotechnology, Government of India, selected Navitas Life Sciences as the CRO to monitor three trials and generate data acceptable to global regulators.
Niche Global experience in stem cell therapy
Niche Global experience in stem cell therapy
In a Phase II rescue trial for a US sponsor, we worked with Indian regulators, ICMR, and DCGI, contributing to draft guideline development. Other studies addressed safety concerns by forming a Data Safety Monitoring Board (DSMB) and secured approval for stroke stem cell therapy under Malaysian regulations.
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Structured monitoring and expertise for LTFU of upto 15 years for delayed side effects and treatment durability through biomarker assessments, active AE reporting, and PROs. Special emphasis on insertional mutagenesis, secondary cancers years, chronic GVHD, and long-term tissue toxicity affecting organ function, and persistent immune responses.
Reputation
Reputation
The Department of Biotechnology, Government of India, selected Navitas Life Sciences as the CRO to monitor three trials and generate data acceptable to global regulators.
Niche Global experience in stem cell therapy
Niche Global experience in stem cell therapy
In a Phase II rescue trial for a US sponsor, we worked with Indian regulators, ICMR, and DCGI, contributing to draft guideline development. Other studies addressed safety concerns by forming a Data Safety Monitoring Board (DSMB) and secured approval for stroke stem cell therapy under Malaysian regulations.
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Long-Term Follow-Up (LTFU) in Cell and Gene Therapy
Structured monitoring and expertise for LTFU of upto 15 years for delayed side effects and treatment durability through biomarker assessments, active AE reporting, and PROs. Special emphasis on insertional mutagenesis, secondary cancers years, chronic GVHD, and long-term tissue toxicity affecting organ function, and persistent immune responses.

    Stem Cell Clinical Trial Services – Client Testimonial

    We thoroughly enjoyed working with Navitas Lifesciences. Navitas team responds in a positive and timely manner and with a good sense of efficiency and priority to achieve the desired results and take the study forward. All documents were perfectly filed, and records maintained. In our phase 3 trial, it was very difficult to recruit and follow up on patients due to COVID 19 pandemic, but I would like to thank the Navitas team for their efforts in completing the patient recruitment and successfully following up on patients in such challenging times.

    I would like to congratulate the biostatistics team and the medical writing team for doing an excellent work. It was a pleasure working with the Navitas team and we would thank the team for their effort in successfully completing the study.


    Brochure

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    Efficient Clinical Trials: Real-Time Oversight & Insights

    Find out how Navitas Life Sciences ensures adherence to study timelines through In-depth domain expertise, robust medical and scientific talent pool, adoption and use of proven technologies.

    On-Demand Webinar

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    Risk Mitigation in Gene Therapy Clinical Trials Development

    Listen to our On-demand webinar as our subject matter experts explores key themes including risk mitigation, gene therapy in diabetes and opportunities and Challenges.

    ARTICLE

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    Novel approaches in early phase Oncology trials to revolutionize Cancer care

    Published in: PharmaFocus Asia
    Explore how the pursuit for effective treatment modalities for cancer rides on sustained efforts with catalyzed adoption of technological advancements that surpass traditional paradigms.

    Stem Cell Clinical Trial Experiences End to End Execution

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    Gain the Navitas Life Sciences Edge

    Holistic Approach

    Holistic Approach

    Balancing scientific rigor with cost-effectiveness.
    8 Offices World Wide

    8 Offices World Wide

    Including 4 delivery centers across the globe.

    Specialized Focus

    Specialized Focus

    Expertise in vulnerable populations and niche areas.
    Strategic Support

    Strategic Support

    From TPP to regulatory compliance, we cover all bases.
    Expert Team

    Expert Team

    Medical monitors with rich academic and industry experience.

    BLOGS

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    Clinical Experts Speak: From Gene Therapy to Digital Registries

    Navitas Life Sciences has vast experience and expertise to discuss strategies in well structured webinars that are a must watch.
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    How We Remain Preferred Clinical Partners for U.S. Federal Agencies

    Find out how Navitas Clinical Research found its strategic footing and helped support numerous U.S. Federal agencies.
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    50 Sponsor Reviews You Must Read

    Here is a collection of sponsor reviews of the stellar work that we provided them with, rethinking strategies and shifting priorities, even during the throes of the COVID-19 pandemic.

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