相关临床试验
9
5 进行中
药物批准
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监管机构
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监管机构数
成立时间
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进行中（未招募）
2
22.2%
尚未招募
3
33.3%
招募中
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44.4%
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- Researchers from ICMR-NIRWoH and IIT Bombay have developed an indigenous placenta-on-chip platform that recreates key functions of the human placental barrier, published in the journal Biofabrication. - The platform successfully reproduces hormone production, nutrient transfer, waste exchange, and selective barrier function, and can model hyperglycaemic conditions resembling gestational diabetes. - Unlike existing systems requiring complex microfluidic equipment, the Indian platform is designed to be simple, scalable, and compatible with conventional laboratory workflows for broader adoption. - The technology may provide new insights into pregnancy complications such as gestational diabetes, fetal growth restriction, and pre-eclampsia, while reducing reliance on animal models.
- The median real-world vein-to-vein time for a leading CAR-T therapy is 27 days, and shorter intervals are associated with meaningfully better complete-response rates and survival. - Most cell and gene therapies require storage at −150°C or colder, far beyond conventional pharmaceutical cold chain capabilities, with fresh un-frozen cells degrading within 12–96 hours. - Hospital readiness remains the defining access barrier across APAC, with Tier-2 regional centres frequently unqualified to receive cryogenic therapies even when the cold chain reaches the airport. - Point-of-care manufacturing, exemplified by India's NexCAR19 priced near US$50,000, offers an alternative model with vein-to-vein times of 7–14 days and no intercontinental cold chain dependency.
- Researchers from IIT Bombay and Monash University have developed a safer and more efficient method to retrieve lab-grown T-cells from electrospun scaffolds, addressing a major bottleneck in CAR T-cell therapy manufacturing. - The new technique using accutase enzyme instead of trypsin significantly improves T-cell survival rates and maintains functional integrity, with recovered cells forming healthier clusters essential for cell division. - The breakthrough could help make CAR T-cell therapy more accessible and cost-effective, particularly relevant as India develops its own CAR T-cell programs to provide affordable alternatives to expensive international treatments. - Published in Biomaterials Science, the findings address cell recovery challenges that directly impact therapy outcomes, as higher yields of viable T-cells improve chances of successful immune responses against cancer.
- Alkem Foundation and IIT Bombay announce a strategic collaboration to establish India's first research centre dedicated to immuno-therapeutics and regenerative medicines. - The partnership represents the country's first industry-academia CSR initiative in this field, with Alkem Foundation committing 20-25% of its CSR obligations over seven years. - The new centre will focus on developing high-precision therapies including cell and gene therapy, gene editing, and advanced delivery platforms for complex diseases with unmet medical needs. - The collaboration aims to create a national model for industry-academia partnerships and position India as a global leader in applied biotechnology and precision medicine.
- Entvin AI, founded by three IIT Bombay graduates, has raised $500K from Y Combinator to streamline the complex FDA drug approval process through specialized AI solutions. - The company's AI platform automates regulatory documentation, compliance verification, and monitoring tasks, with early users reporting hundreds of hours saved in manual regulatory work. - Entvin AI aims to accelerate pharmaceutical development timelines and reduce compliance costs in a multi-billion-dollar market, addressing critical inefficiencies that delay life-saving treatments.
- President Droupadi Murmu launched India's first indigenously-developed CAR-T cell therapy, NexCAR19, marking a major breakthrough in the country's battle against cancer. - The therapy, developed through collaboration between IIT Bombay and Tata Memorial Centre with industry partner ImmunoACT, costs approximately one-tenth the price of international alternatives. - NexCAR19 represents the world's most affordable CAR-T cell therapy, making this advanced cancer treatment accessible to patients who previously couldn't afford the ₹4 crore international cost. - The launch positions India among the few countries capable of producing indigenous cellular therapy and demonstrates successful academia-industry partnership in biotechnology innovation.
- India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States. - Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission. - Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.
