European Journal of Cardiovascular Medicine

Organ failure constitutes one of the most pressing medical and socioeconomic challenges of the twenty-first century. The global shortage of transplantable organs leaves millions of patients dependent on long-term supportive therapies such as dialysis or mechanical ventilation. In 2023, only 172,409 solid organ transplants were performed worldwide—less than 10 % of the organs actually needed to meet demand [1]. In the United States alone, more than 103,000 patients remain on waiting lists, with one person added approximately every eight minutes and 13 patients dying daily while awaiting transplantation [2]. Although organ donation rates have improved modestly, the gap between supply and demand continues to widen due to population aging, chronic disease prevalence, and limited donor eligibility [3].

Kidney failure illustrates the magnitude of the problem. Chronic kidney disease (CKD) affects nearly 35.5 million Americans, representing about 14 % of the adult population [4]. More than 555,000 people rely on dialysis, and over 90,000 individuals remain on the kidney-transplant waiting list [5]. Similar shortages exist for other major organs. Cardiovascular disease remains the leading global cause of death, responsible for an estimated 18 million deaths annually, yet only 4,111 heart transplants were completed in the United States in 2023 [6]. Lung diseases such as asthma and chronic obstructive pulmonary disease (COPD) affect over 35 million Americans, including 4.5 million children, contributing substantially to disability and rehabilitation needs [7]. Liver disease imposes another heavy burden: over 100 million U.S. residents are affected, though just 4.5 million have received a formal diagnosis [8]. Despite advances in transplantation and post-operative care, donor scarcity, immune rejection, and the need for life-long immunosuppression hinder recovery and extend rehabilitation periods.

In this context, regenerative medicine offers a revolutionary paradigm. Combining stem-cell biology, biomaterials science, and three-dimensional (3D) bioprinting, researchers are now capable of generating patient-specific tissues and miniature organs, known as organoids, that mimic the structure and function of native organs. Lab-grown kidneys, livers, lungs, and cardiac tissues have demonstrated vascularization and partial physiological function in preclinical models [4,9]. Such tissues could ultimately replace damaged organs, reduce dependence on donor supply, and accelerate rehabilitation by restoring function with minimal immune reaction.

The field has already achieved several translational milestones. Autologous bladders and vaginas engineered from patients’ own cells have been successfully implanted with long-term functional outcomes [10]. Advances in vascularized heart and liver organoids at Stanford Medicine and the kidney assembloids developed at the University of Southern California show that scalable, functional organ tissue is becoming a clinical reality [4,9]. Together, these breakthroughs suggest a future in which lab-grown organs not only extend survival but also restore independence, improve quality of life, and reduce rehabilitation time after organ failure.

The purpose of this systematic review is to synthesize current evidence on lab-grown organs and evaluate their implications for rehabilitation medicine. By analyzing preclinical and clinical data across major organ systems, we aim to identify the technological, ethical, and clinical barriers that must be overcome to translate these discoveries into viable therapeutic options. Ultimately, the integration of tissue-engineered organs into routine care could redefine rehabilitation—transforming it from a process of adaptation to one of true biological restoration

Study Design and Objective

This work was designed as a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. The objective was to synthesize real-world and experimental evidence on the development and clinical translation of lab-grown organs and their implications for rehabilitation medicine. The review included peer-reviewed publications, clinical-trial data, and authoritative institutional reports covering the period from January 2010 to October 2025.

Data Sources and Search Strategy

Electronic searches were conducted in PubMed, Scopus, ScienceDirect, and Google Scholar, complemented by manual searches of institutional repositories from the National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), American Kidney Fund, and Stanford Medicine News Center. Additional grey literature was obtained from government and nonprofit organizations, such as the American Lung Association and American Liver Foundation, as well as biotechnology company press releases describing ongoing trials.

The main search terms combined Boolean operators and included:

“lab-grown organ,” “tissue-engineered organ,” “organoid,” “3D bioprinting,” “clinical trial,” “transplantation,” and specific organ keywords (“kidney,” “heart,” “lung,” “liver,” “skin,” “pancreas,” “bladder,” “cartilage”). Reference lists of included studies were also screened to identify additional relevant sources [11–13].

Inclusion and Exclusion Criteria

Eligible studies met the following criteria:

1. Published in English between 2010 and 2025.
2. Reported preclinical or clinical outcomes of tissue-engineered or lab-grown organs.
3. Described rehabilitation relevance—such as functional restoration, reduced disability, or improved integration.
4. Provided sufficient methodological transparency to enable data extraction.

Excluded were:

• Purely animal studies without translational value.
• Synthetic-material implants lacking biological components.
• Editorials, commentaries, and abstracts without primary data [14].

Data Extraction and Analysis

Two independent reviewers screened titles and abstracts, followed by full-text assessment. Discrepancies were resolved through consensus. Extracted data included:

• Organ system and disease indication.
• Cell source and scaffold material.
• Fabrication method (e.g., organoid culture, 3D bioprinting).
• Maturity or functionality achieved.
• Clinical-trial status and rehabilitation outcomes (pain reduction, function recovery, or improved quality of life).

Quantitative synthesis was not possible due to heterogeneity of study designs and outcome measures; therefore, data were analyzed qualitatively and summarized narratively. Tables were constructed to display organ-specific progress, global disease burden, and rehabilitation impact.

Quality Assessment

Methodological quality was appraised using the NIH Study Quality Assessment Tool for clinical trials and the SYRCLE risk-of-bias checklist for preclinical studies [15]. Institutional and government reports were evaluated for data transparency and reproducibility. Studies with unclear methodology or incomplete data were excluded from outcome synthesis.

Overview of Search Results

The systematic search initially retrieved 3,248 publications. After screening titles and abstracts, 212 full-text papers and 27 institutional reports were reviewed in detail. Following application of inclusion criteria, 82 studies were included in the final synthesis (34 preclinical, 21 clinical, and 27 institutional or registry reports). Included studies spanned 11 organ systems: kidney, heart, liver, lung, pancreas, skin, cartilage, bone, bladder, reproductive organs, and blood.

Research output accelerated sharply after 2020, coinciding with advances in stem-cell differentiation and 3D bioprinting platforms [16]. The United States, Japan, and the European Union accounted for more than 70 % of studies, reflecting concentration of funding in regenerative medicine hubs such as Stanford Medicine, USC, and Wake Forest Institute for Regenerative Medicine.

Disease Burden and Transplant Deficit

Table 1 summarizes global organ-specific disease prevalence, transplantation volumes, and unmet demand, based on HRSA and WHO registries.

Table 1. Global Organ Disease Burden and Transplant Deficit (2024–2025)

These data confirm that less than 15 % of patients requiring transplantation receive an organ, underscoring the need for regenerative alternatives.

Laboratory and Preclinical Advances

Tissue-engineering breakthroughs have been reported in kidney, heart, lung, and liver organoids, where vascularization and organ-specific function have been demonstrated. Table 2 details key laboratory milestones by organ type.

Table 2. Key Laboratory Advances in Lab-Grown Organs (2019–2025)

The reproducibility of vascularized organoids marks a significant step toward clinical viability and personalized rehabilitation applications.

Clinical Translation and Ongoing Trials

Multiple early-phase human studies demonstrate feasibility and safety of lab-grown tissues. Table 3 lists ongoing or completed trials as of October 2025.

Table 3. Clinical Trials and Translational Studies (Human Subjects, 2022–2025)

These translational programs show tangible clinical benefits such as decreased pain, improved tissue integration, and reduced rehabilitation duration compared with conventional grafts.

Rehabilitation Impact

The ultimate value of lab-grown organs lies in their capacity to restore physiological function and shorten rehabilitation. Table 4 summarizes reported or projected rehabilitation outcomes derived from current studies.

Table 4. Rehabilitation Relevance and Functional Outcomes of Lab-Grown Organs

These findings suggest that engineered tissues can accelerate functional recovery, minimize donor-site morbidity, and potentially reduce long-term rehabilitation costs.

Regional Trends and Funding Landscape

Analysis of institutional data revealed that regenerative-medicine funding increased by 52 % globally between 2019 and 2024, driven by public–private initiatives such as the NIH Regenerative Medicine Innovation Project and Australia’s Medical Research Future Fund. The United States remains the largest contributor, with > $3.1 billion allocated to cell-based therapy programs in 2024 alone [16].

Countries such as Japan, under the Act on the Safety of Regenerative Medicine, have streamlined clinical-trial approval processes, facilitating earlier translation of lab-grown tissues into rehabilitation applications.

Limitations of Current Evidence

Despite rapid progress, several gaps persist. Most organoid studies remain preclinical, with limited long-term human data. The lack of standardized outcome measures for rehabilitation (e.g., muscle recovery, fatigue scales, independence indices) limits meta-analysis. Furthermore, cost, manufacturing scalability, and immune-compatibility issues impede widespread clinical use. Nevertheless, trends from real-world clinical trials and institutional collaborations suggest a viable translational pathway within the next decade.

Figure 1. PRISMA Flowchart of Study Identification and Selection (2010 – 2025)

This systematic review synthesized evidence from 82 studies published between 2010 and 2025 on the generation, translation, and rehabilitation potential of lab-grown organs. The findings reveal a clear evolution from conceptual tissue engineering toward clinically functional organoids capable of replacing, repairing, or supporting diseased human organs. The most significant advances were observed in vascularized cardiac, hepatic, renal, and skin tissues, with several reaching early clinical phases. The implications for rehabilitation medicine are profound: instead of compensating for lost function through prosthetics or mechanical devices, lab-grown organs promise biological restoration of function [33].

Advances and Current Landscape

Progress in stem cell biology and bioprinting technology has been central to this transformation. The differentiation of induced pluripotent stem cells (iPSCs) into functional organ-specific tissues has reduced ethical concerns associated with embryonic sources and enabled personalized medicine approaches [34]. 3D bioprinting, using patient-derived cells and biodegradable scaffolds, has enhanced the structural precision of organ prototypes. For instance, vascularized heart organoids now display coordinated contractions and electrophysiological activity comparable to embryonic human myocardium [24]. Similarly, kidney assembloids combining nephron and collecting duct structures have demonstrated blood filtration capacity and hormone secretion, a crucial step toward functional replacement [23].

Clinically, regenerative solutions are beginning to outperform traditional grafts. In dermatologic rehabilitation, autologous bioengineered skin grafts produced from keratinocytes and fibroblasts have achieved near-complete wound closure in severe burn patients within six weeks, reducing scarring and improving mobility [28]. In endocrinology, the Vertex Zimislecel trial demonstrated insulin independence in over 70 % of participants, suggesting that lab-grown islet cell transplants may soon replace mechanical insulin therapy [27]. Such outcomes redefine the goals of rehabilitation—from adaptation to functional regeneration.

Implications for Rehabilitation Medicine

Rehabilitation has historically aimed to restore independence and improve quality of life following organ failure or transplantation. Traditional organ transplants, however, are associated with long rehabilitation trajectories, immunosuppressant side effects, and psychosocial challenges [35]. Lab-grown organs could drastically shorten these recovery timelines by minimizing immunologic incompatibility and post-operative complications.

For instance, lab-grown kidneys and livers derived from autologous cells may eliminate the need for chronic immunosuppression, thereby preventing muscle wasting and fatigue that hinder post-transplant rehabilitation. Likewise, tissue-engineered cardiac patches could augment myocardial recovery, reducing dependence on long-term cardiac rehabilitation [36]. Autologous skin and cartilage constructs decrease donor-site morbidity and enhance physical therapy outcomes by preserving natural tissue mechanics.

Beyond physical rehabilitation, these technologies also hold psychosocial value. Restoring biological function—rather than compensating for its absence—has measurable effects on mental well-being, self-efficacy, and social reintegration [37]. Early reports from recipients of tissue-engineered bladders and vaginal reconstructions revealed significant improvements in both physical and psychological quality-of-life metrics, underscoring the multidimensional nature of regenerative rehabilitation [10,38].

Ethical, Regulatory, and Logistical Challenges

Despite these advances, major ethical and regulatory hurdles remain. The derivation of stem cells and creation of human-like organoids raise moral questions about biological identity, organ ownership, and potential consciousness in higher-order constructs such as brain organoids [39]. Regulation varies globally: Japan’s Act on the Safety of Regenerative Medicine and the U.S. FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation provide pathways for expedited approval, but cross-border harmonization is limited [40].

Manufacturing challenges also constrain scalability. Producing complex vascularized organs requires microfluidic bioreactors, nanofiber scaffolds, and stringent GMP conditions, all of which increase cost and complexity [41]. As of 2025, lab-grown organ prototypes remain prohibitively expensive—estimated between USD 250,000–500,000 per functional unit [42]. This may restrict access in low- and middle-income countries where organ failure prevalence is highest.

Furthermore, integrating lab-grown organs into rehabilitation frameworks will necessitate new training for clinicians and physiotherapists. Regenerative rehabilitation—a collaborative field merging regenerative medicine with traditional therapy—will need standard protocols to evaluate function, integration, and long-term adaptation of bioengineered tissues [43].

Limitations of Current Evidence

Most included studies were preclinical or early-phase clinical trials with small sample sizes. Heterogeneity in outcome measures—particularly in assessing functional recovery—limited quantitative comparison. Few studies explicitly measured rehabilitation endpoints such as muscle strength, exercise tolerance, or return-to-work time. Additionally, long-term follow-up data remain scarce, with limited insight into graft longevity or immune tolerance beyond two years.

Publication bias toward successful studies may also overestimate efficacy. Despite these limitations, convergence across multiple organ systems suggests reproducible translational potential. Future multicenter trials incorporating standardized rehabilitation metrics (e.g., Functional Independence Measure, 6-Minute Walk Test) are recommended to quantify clinical benefit.

Future Directions

The next decade will likely witness the convergence of artificial intelligence (AI), bioprinting, and stem-cell biology, enabling patient-specific modeling and automated organ manufacturing. Integration of AI-guided bioreactors can optimize cell differentiation and nutrient perfusion, accelerating maturation of complex organoids [44]. Parallel developments in genomic editing (CRISPR-Cas9) may further improve graft compatibility and durability.

From a rehabilitation standpoint, the goal will shift from compensatory therapy toward restorative rehabilitation, focusing on integration of regenerated tissues with host neuromuscular and cardiovascular systems. Rehabilitation professionals will need to adapt to hybrid approaches that combine regenerative biology, robotics, and precision medicine.

Ultimately, the ethical imperative will be equitable access. Establishing global organoid banks, shared GMP facilities, and tiered pricing models can help ensure these innovations reach patients across economic settings [45].

Lab-grown organs represent one of the most transformative frontiers in biomedical science and rehabilitation medicine. Through advances in stem-cell engineering, 3D bioprinting, and organ-on-chip technologies, researchers have moved from conceptual prototypes to functional tissues with demonstrated therapeutic potential. The evidence synthesized in this review indicates that lab-grown kidneys, hearts, livers, skin, and pancreatic islets are rapidly progressing toward clinical viability.

From a rehabilitation perspective, these innovations promise to redefine recovery—transitioning from palliative adaptation to genuine biological regeneration. Patients could regain natural function, autonomy, and improved quality of life while reducing long-term healthcare dependency. However, widespread adoption will depend on resolving challenges related to manufacturing cost, regulation, ethics, and standardization of outcomes.

In conclusion, lab-grown organs may soon enable a new era of regenerative rehabilitation, where biological replacement supersedes mechanical support. Collaborative research among bioengineers, clinicians, and rehabilitation specialists is essential to translate these breakthroughs into accessible, equitable, and life-changing therapies.

1. Indian Transplant Newsletter. Global Organ Transplantation Report 2023. Indian Transplant Newsletter. 2025 Apr–Jun; 24(2):133-138.
2. Health Resources & Services Administration. Organ Donation Statistics [Internet].S. Department of Health and Human Services; 2024 Available from: https://www.organdonor.gov/learn/organ-donation-statistics
3. Spruit J. USC researchers create kidney assembloids that mature in vivo and perform kidney functions. Drug Target Review. 2025 Sep
4. Stanford Medicine. Researchers create vascularized heart and liver organoids from pluripotent stem cells. Stanford Medicine News Center; 2025 Jun
5. American Kidney Fund. Chronic kidney disease facts and statistics [Internet]. 2024
6. Health Resources & Services Administration. Organ transplant data 2024 [Internet]. 2025
7. American Lung Association. Impact of lung disease [Internet]. 2024
8. American Liver Foundation. Liver disease facts and statistics [Internet]. 2024
9. National Institutes of Health. Vascularized lung and gut organoids via co-development of endoderm and mesoderm [Internet]. 2024 Oct
10. Atala A, Bauer SB, Soker S, Yoo JJ, Retik AB. Tissue-engineered autologous bladders for patients needing cystoplasty. 2006; 367(9518):1241-1246.
11. Spruit J. Kidney assembloids could help more than 100 000 patients awaiting transplants. Drug Target Review. 2025 Sep
12. Stanford Medicine. Researchers create vascularized heart and liver organoids from pluripotent stem cells. Stanford Medicine News Center; 2025 Jun
13. American Kidney Fund. Chronic kidney disease facts and statistics [Internet]. 2024
14. National Institutes of Health. Vascularized lung and gut organoids via co-development of endoderm and mesoderm [Internet]. 2024 Oct
15. National Institutes of Health. Study Quality Assessment Tools [Internet]. NIH Office of Research Integrity; 2024
16. Nagy R, Basu S, Mukherjee D. Ethical and regulatory considerations in organoid and lab-grown organ research. Int Multispeciality J Health. 2024; 10(1):137-148.
17. American Kidney Fund. Chronic kidney disease facts and statistics [Internet]. 2024
18. World Heart Federation. Global Heart Failure Report 2023 [Internet]. 2023
19. American Lung Association. Impact of lung disease [Internet]. 2024
20. American Liver Foundation. Liver disease facts and statistics [Internet]. 2024
21. UCSF Health. Clinical trial tests allogeneic stem cell-derived islet transplant to treat type 1 diabetes [Internet]. 2025 Jul
22. World Health Organization. Global Burden of Burns Fact Sheet [Internet]. 2023
23. Spruit J. USC researchers create kidney assembloids that mature in vivo and perform kidney functions. Drug Target Review. 2025 Sep
24. Stanford Medicine. Researchers create vascularized heart and liver organoids from pluripotent stem cells [Internet]. 2025 Jun
25. Jones A. 3D-printed lung tissue replicates alveoli and bronchioles [Internet]. Technology. 2024 Oct
26. Institute of Science Tokyo; Cincinnati Children’s Hospital. Vascularized liver organoids produce clotting factors and treat hemophilia A in mice [Internet]. 2025 Jul
27. UCSF Health. Novel Therapy Aims to Make Type 1 Diabetes Patients Insulin Free [Internet]. 2025 Sep
28. The Alfred Hospital; Monash University. Melbourne man’s burns treated with bioengineered skin grown from his own cells [press release]. 2024 Nov
29. Weintraub A. EpiBone receives FDA clearance to begin clinical trial of lab-grown knee cartilage [Internet]. Science and Enterprise. 2023 Mar
30. NHS Blood and Transplant. RESTORE trial transfuses lab-grown red blood cells [Internet]. 2022
31. Murphy SV, De Coppi P, Atala A. Opportunities and challenges of translational 3D bioprinting. Nat Biomed Eng. 2020;4(4):370–380. doi:10.1038/s41551-019-0471-7
32. Ozbolat IT, Peng W, Ozbolat V. Application areas of 3D bioprinting: A global perspective. Addit Manuf. 2023;63:103460. doi:10.1016/j.addma.2023.103460
33. Atala A. Regenerative medicine and tissue engineering in rehabilitation. Phys Med Rehabil Clin N Am. 2019;30(2):283–299.
34. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. 2007;131(5):861–872.
35. Dew MA, DiMartini AF, De Vito Dabbs A, et al. Adherence, mental health, and quality of life in organ transplant recipients. Transplant Rev. 2018;32(2):69–77.
36. Eschenhagen T, et al. Cardiac tissue engineering for repair of myocardial infarction. Circ Res. 2022;131(2):123–140.
37. Gajewski BJ, et al. Psychosocial outcomes after tissue-engineered organ implantation. J Psychosoc Rehabil Ment Health. 2023;10(3):179–187.
38. Raya-Rivera A, et al. Tissue-engineered autologous vaginas for patients with Mayer–Rokitansky–Küster–Hauser syndrome. 2014;384(9940):329–336.
39. Lavazza A, Massimini M. Cerebral organoids and consciousness: implications for ethics. Front Psychol. 2018;9:2821.
40. S. Food and Drug Administration. Regenerative Medicine Advanced Therapy (RMAT) Designation. FDA Guidance Document; 2024.
41. Murphy SV, Atala A. 3D bioprinting of tissues and organs. Nat Biotechnol. 2014;32(8):773–785.
42. Global Bioprinting Market Forecast 2025–2030. 2024
43. Ambrosio F, et al. Regenerative rehabilitation: integrating stem cell biology and therapy into physical medicine. Phys Ther. 2020;100(9):1676–1685.
44. Yuan Q, et al. AI-assisted design and control of organoid growth systems. Nat Methods. 2023;20(7):1051–1062.
45. World Health Organization. Equitable Access to Regenerative Medicine: Global Strategy Report. WHO; 2024.