RESEARCH ARTICLE
Open Access

Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study

Rajesh Kumar Sharma1,Priya Menon2,Arjun Patel3* ORCID 

¹ Department of Stem Cell Biology and Regenerative Medicine, All India Institute of MedicalSciences (AIIMS), New Delhi,India.
² Department of Biotechnology, Christian Medical College (CMC), Vellore, Tamil Nadu, India.
3 Centre for Translational Medicine, Institute of Medical Sciences, Banaras Hindu University (BHU), India.
DOI: 10.18081/ajbm.2026.2.176

Publication History: Received 29 March 2026, Revised 17 April 2026, Accepted 24 May 2026, Available online 29 June 2026
Copyright: © 2026 Patel, et al. This is an open-access article under a Creative Commons license (CC BY 4.0).
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ABSTRACT

Background

Induced pluripotent stem cells (iPSCs) offer a patient-specific platform for tissue regeneration, disease modeling, and personalized therapy. However, clinical evidence regarding the feasibility, safety, and therapeutic effectiveness of autologous iPSC-derived interventions remains limited, particularly within the Indian healthcare setting. This study evaluated the clinical translation of autologous iPSC-based regenerative therapy in patients with chronic degenerative diseases.

Methods

This prospective, multicenter observational study enrolled 102 adults treated at three tertiary care centers in India. Peripheral blood mononuclear cells were reprogrammed using a non-integrating Sendai viral vector and differentiated into disease-specific therapeutic progenitor cells under xeno-free, Good Manufacturing Practice-compatible conditions. Participants received 5 × 10⁶ to 2 × 10⁷ viable autologous cells through disease-appropriate administration routes. Clinical function, quality of life, inflammatory biomarkers, imaging findings, and adverse events were assessed at baseline and at 1, 3, 6, and 12 months. Longitudinal outcomes were analyzed using repeated-measures analysis of variance, and predictors of favorable response were evaluated by multivariable logistic regression.

Results

Clinically suitable iPSC lines were successfully generated for 98 of 102 participants (96.1%). Mean functional scores improved from 46.8 ± 8.9 at baseline to 71.4 ± 10.6 at 12 months, while quality-of-life scores increased from 52.3 ± 11.7 to 78.6 ± 9.8 (both P < .001). Significant reductions were observed in C-reactive protein, interleukin-6, and tumor necrosis factor-α concentrations. Marked radiological improvement occurred in 72 participants (70.6%), and the overall favorable clinical response rate was 80.4%. Fifteen participants experienced mild or moderate adverse events. No treatment-related death, tumor formation, severe immune reaction, or opportunistic infection was identified during follow-up. Younger age, shorter disease duration, and higher cell viability independently predicted a favorable response.

Conclusion

Autologous iPSC-derived therapy was feasible and associated with improved functional, biochemical, and radiological outcomes over 12 months, with an acceptable short-term safety profile. Larger randomized, disease-specific trials with extended surveillance are required before routine clinical implementation.

Keywords: Induced pluripotent stem cells; Regenerative medicine; Autologous cell therapy; Clinical translation; Inflammatory biomarkers.

Recommended Citation

Sharma RK, Menon P, Patel A. Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study. Advanced Journal of Biomedicine & Medicine. 2026;14(2):176-193. doi:10.18081/ajbm.2026.2.176

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Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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2026 Vol 14, Issue 2 Pages 176-193

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Sharma RK, Menon P, Patel A. (2026). Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> . Advanced Journal of Biomedicine & Medicine, 14(2), 176-193. https://doi.org/10.18081/ajbm.2026.2.176
Sharma RK, Menon P, Patel A.. " Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> ." Advanced Journal of Biomedicine & Medicine, vol. 14, no. 2, 2026, pp. 176-193. DOI: 10.18081/ajbm.2026.2.176.
Sharma RK, Menon P, Patel A.. Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> . AJBM. 2026;14(2):176-193. DOI: 10.18081/ajbm.2026.2.176. PMID: .
Sharma RK, Menon P, Patel A. 2026, " Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> ", Advanced Journal of Biomedicine & Medicine, vol. 14, no. 2, pp. 176-193.
@article{sharma2026, title={ Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> }, author={Sharma RK, Menon P, Patel A.}, journal={Advanced Journal of Biomedicine & Medicine}, volume={14}, number={2}, pages={176-193}, year={2026}, doi={10.18081/ajbm.2026.2.176} }
TY - JOUR AU - Sharma RK, Menon P, Patel A. TI - Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> JO - American Journal of Biomedicine VL - 14 IS - 2 SP - 176-193 PY - 2026 DO - 10.18081/ajbm.2026.2.176 ER -
%0 Journal Article %A Sharma RK, Menon P, Patel A. %T Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> %J American Journal of Biomedicine %V 14 %N 2 %P 176-193 %D 2026 %R 10.18081/ajbm.2026.2.176 %M
Sharma RK, Menon P, Patel A. (2026). Clinical Outcomes of Autologous Induced Pluripotent Stem Cell-Derived Therapy in Patients with Chronic Degenerative Diseases: A Prospective Multicenter Study<br /> . Advanced Journal of Biomedicine & Medicine, 14(2), 176-193. https://doi.org/10.18081/ajbm.2026.2.176

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