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Regenerative Medicine Clinical experience with the use of ASCs to repair and regenerate tissues and organs continues to expand rapidly and in this section we present summaries of the latest peer reviewed publications.
Click on the left pane to read the summary texts and on the 1st author’s name to see the full reference in the Cryo-Lip bibliography. We will update the content regularly but an easy way to stay updated about recent publications is to subscribe to our quarterly Cryo-Lip eNewsletter. |  |
Cardiac Disease
Several in vivo studies in different animal models have shown that ASCs can
| Cai 2008 | |
| Léobon 2008 | |
| Kondo 2008 |
This evidence led to clinical trials, the first of which started in 2007. Interim results for two studies were announced recently and are summarized below.
| Duckers, H | Ongoing study, 1st results 2010 | ASCs in Acute Myocardial Infarction, ClinicalTrials.gov Identifier: NCT00442806 |
| Design | Randomized, placebo controlled trial in 48 patients
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| Inclusion | Acute MI (within 24 hrs) with ST elevation | ||
| Endpoints | primary safety secondary assessment of cardiac function via functional and imaging studies | ||
| Method | Injection of ASCs obtained from liposuction on same day vs placebo injection | ||
| Results | 6 months results, presented at Int Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, 2010 | ||
Mean infarct size ASC group reduced from 32% to 15% vs no change in placebo group at 25% Left ventricular perfusion 3.5 times improved in ASC group vs 1.7 in placebo Ejection fraction 6% improvement with ASCs vs -2% in palcebo group | |||
| Conclusion | Dramatic improvements at 6 month follow-up promise a new way to treat acute MI. Longer term follow-up ongoing. | ||
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| Fernandez-Avilez, F | Ongoing study, 1st results 2010 | ASCs in Chronic Myocardial Ischemia, ClinicalTrials.gov Identifier: NCT00426868 |
| Design | Randomized, double blind, placebo controlled trial in 27 patients | |||
| Inclusion | No option coronary artery disease, life expectancy > 1 year | |||
| Endpoints | primary safety secondary assessment of cardiac function via functional and imaging studies | |||
| Method | Injection of ASCs obtained from liposuction vs placebo injection | |||
| Results | 6 months results, presented at Int Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, 2010 | |||
| Liposuction and ASC injection were safe with no SAEs | ||||
Max O2 consumption MVO2 increase in ASC group vs deterioration in placebo (p < 0,05) Aerobic capacity improved by 0.2 points in ASC group vs deterioration in placebo of 0.8 (p < 0,05) Severity heart disease improvement of 66% vs 33% in favor of SC group | ||||
| Conclusion | Encouraging results in difficult patient group, consistent with preclinical evidence. longer term follow-up ongoing. | |||
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Skin Regeneration
ASCs have been shown to have positive effects in skin repair and regeneration, and the first summary below highlights the mechanisms of action. In vivo evidence and first reports of benefical effects in skin ageing and anti-wrinkle effects follow.
| Kim, WS | Expert Opin Biol Ther | 2009 | The wound healing and antioxidant effects of ASCs |
| Synopsis | Recent research developments show clear wound healing and antioxidant effects of ASCs. ASCs do not differentiate into skin skin cells, but work mainly in a paracrine way by secreting cytokines and growth factors. Skin repair effetcs are mainly mediated by the activation of dermal fibroblasts and keratinocytes. | ||
| Conclusion | ASCs show great promise for use in skin repair and regeneration | ||
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| Nambu, M | Ann Plast Surg | 2009 | ASCs accelerate wound healing in diabetic healing-impaired mice |
| Design | Controlled experiment, n = 12, two full thickness round skin defects. Histologic sections evaluated after 1 and 2 weeks. | ||
| Results | ASC group significantly improved granulation tissue, capillary formation and epithelialization. | ||
| Conclusion | In vivo evidence show ASCs significantly accelerate wound healing | ||
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| Park, BS | Derm Surg | 2008 | ASCs and their secretory factors a promising therapy for skin aging |
| Synopsis | In vivo part of study showed that ASCs prodcue many useful growth factors, including collagen production.
In a case study that followed one patient showed reversal of skin aging. | ||
| Conclusion | ASCs show promise in the treatment of skin aging | ||
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Urinary Incontinence
| Mitterberger, M | J Urol | 2008 | Autologous MSC therapy for post-prostatectomy urinary incontinence |
| Design | 63 males with SUI after radical prostatectomy, treatment trial, 1 year follow-up | ||
| Method | Transurethral ultrasound guided injections of autologous MSCs (fibroblasts and myoblasts) Measured urodynamics, incontinence, QoL, morphology and function of urethra and rhabdosphincter | ||
| Results | After 12 months 41 patients were continent, 17 improved and 5 no change | ||
| Conclusion | MSC therapy is minimally invasive, safe and effective for post-prostatectomy incontinence | ||
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| Yamamoto,T | Int J Urol | 2009 | Periurethral injection of ASCs for urinary incontinence after radical prostatectomy |
| Design | Two patients with moderate stress incontinence after radical prostatectomy 12 week follow-up | ||
| Method | ASCs obtained via abdominal liposuction (250 ml) Injected transurethrally with adipose tissue into rhabdosphincter and submucosa | ||
| Results | Urinary incontinence progressively improved as measured by - maximum urethral closing pressure and functional profile length - no adverse events | ||
| Conclusion | Local injection of autologous ASCs is feasible and safe treatment for SUI | ||
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Chronic Fistulas (Crohn's)
Several preclinical and in vivo studies have shown why ASCs could be effective in Crohn's disease and and provided the basis for the cliniacl trials that folloowed. Below is a summary of one such in vivo study, followed by clincal reports.
| Gonzalez-Rey, E | GUT | 2009 | ASCs alleviate experimental colitis by inhibiting inflammatory responses |
| Method | Mice with induced colitis were treated with hASCs after onset of disease. Clinical scores as well as inflammatory response and different inflammatory mediators were evaluated. | ||
| Results | hASCs improved the clinical severity of colitis, weight loss, diarrhea, and survival (P < .001). They also decreased a wide panel of inflammatory cytokines and chemokines (P < .001), directly acting on activated macrophages. hASCs also impaired Th1 cell expansion (P < .001).
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| Conclusion | hASCs are attractive candidates for a cell-based therapy for Crohn's disease | ||
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| Garcia-Olmo, D | Int.J.Colorectal Dis. | 2003 | Autologous SCs for Rx of rectovaginal fistula in perianal Crohn's disease |
| Method |
| Case report of young woman with recurrent rectovaginal fistula. ASCs obtained as lipoaspirate were used as a surgical autotransplant. | |
| Results | No vaginal flatus or fecal incontinence after 3 months. | ||
| Conclusion | ASCs seem to be effective, with no ethical and safety problems using autologous SCs | ||
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| Garcia-Olmo, D | Expert. Opin. Biol. Ther. | 2008 | Expanded ASCs in complex perianal fistula: a phase II clinical trial |
| Design | Phase IIb multicenter, randomized controlled trial. 49 patients with complex perianal fistulas (of which 14 with Crohn's disease). | ||
| Method | Intralesional treatment with fibrin glue or fibrin glue plus 20 million ASCs (derived from lipoaspirate). Fistula healing and quality of life (SF-12 questionnaire) were evaluated at eight weeks and one year. | ||
| Results | Fistula healing in (71%) in ASC group vs 16% in fibrin glue alone group (relative risk 4.43, P < 0.001). No difference in Crohn's vs non-Crohn's subgroups. Both treatments were well tolerated. | ||
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| Conclusion | ASCs with fibrin glue is an effective and safe treatment for complex perianal fistula | ||
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