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Abstracts


Regenerative therapy with Stem Cell has become a more frequent treatment for orthopedic conditions in the US, including knee, hip and shoulder osteoarthritic pain.

For those patients with joint pain, the current steps of treatment in U.S. include first, activity modification, physical therapy, and medication management. The next step in the ladder includes steroid or hyaluronic acid intrarticular injection. If this fails, then a total knee or hip replacement is offered to the patient, as the last resort, to control the pain.

Every year around more than a million patients have a total joint replacement in the US (just in the knee and hip), but there are still many patients that do not want a replacement or cannot have it for medical conditions or other matters, leaving them in a limbo for pain control.

Adult Mesenchymal Stem Cells Manage The Body’s Innate Regenerative Capability

Abstract

Marrow derived adult Mesenchymal Stem Cells (MSCs) can be isolated and culture expanded. Although these cells are capable of differentiating into lineages that result in the fabrication of bone, cartilage, muscle, marrow stroma, tendon/ligament, fat and other connective tissues, MSCs have recently been shown to be intrinsically therapeutic. Such culture expanded adult MSCs are immuno-modulatory especially in muting T-cells and, thus, both autologous and allogeneic MSCs have been used to mute or cure graft-versus-host-disease, Crohn’s disease, AMI, MS, diabetes, rheumatoid arthritis, lupus and are now being tested in over 600 clinical trials for a huge spectrum of diseases (clinicaltrials.gov). Furthermore, these MSCs set-up a regenerative micro-environment which is anti-apoptotic, anti-scarring, mitotic for tissue intrinsic progenitors and angiogenic. These immuno and trophic activities result from the secretion of powerful bioactive molecules that, in combination, support localized regenerative event.

The MSCs reside in every tissue of the body and function as perivascular cells (pericytes) until a focal injury occurs. At sites of injury or inflammation, the pericyte is released and functions as a MSC that provides molecular assistance in activities leading to tissue regeneration. Such assistance involves many tasks involving the immuno-protection and trophic activities provided by the MSCs. Although it is proposed that all MSCs are pericytes and have common capacities, it is expected that MSCs from different tissues location or anatomical sites of injury will not be equivalent. Thus, adipose-derived and marrow-derived MSCs naturally reside as pericytes and have different functional capacities. The fact that uncultured, freshly isolated autologous “stromal vascular fraction (SVF)” from fat has been shown to be therapeutically effective strongly argues that the MSCs in the SVF are a potent multi-drug and site-specific delivery vehicle. The important central logic is that MSCs from a number of different tissue sources are all therapeutic for a number of different clinical conditions because they initiate and manage the host’s response capacity. Such management not only results in the arrest of disease processes, but in the regeneration of tissues previously thought to be not capable of such regeneration.

In order to translate stem cell-based therapies from the benchtop to the bedside, there are a number of issues, sometimes real challenges, that need to be addressed.

These are being identified through a technology road map for cell manufacturing that is being developed with funding from the U.S. National Institute for Standards and Technology and with the support of the National Cell Manufacturing Consortium.

The development of this road map also has led to the establishment at Georgia Tech of the Marcus Center for Therapeutic Cell Characterization and Manufacturing. The issues being addressed by the Marcus Center are cell processing including cell expansion, process monitoring and quality control, cell presentation and distribution, the regulatory pathway, and workforce development. These and other issues/challenges will be addressed in this presentation.

Are stem cell therapies ready to become standard of treatment?

Abstract

Regenerative therapy with Stem Cell has become a more frequent treatment for orthopedic conditions in the US, including knee, hip and shoulder osteoarthritic pain.
For those patients with joint pain, the current steps of treatment in U.S. include first, activity modification, physical therapy, and medication management. The next step in the ladder includes steroid or hyaluronic acid intrarticular injection. If this fails, then a total knee or hip replacement is offered to the patient, as the last resort, to control the pain.

Every year around more than a million patients have a total joint replacement in the US (just in the knee and hip), but there are still many patients that do not want a replacement or cannot have it for medical conditions or other matters, leaving them in a limbo for pain control.

Ten years ago, there were no options for those patients in our area, but in 2010 we started to inject a Processed Aspirated Bone Marrow (BMAC) and later Adipose Derived Stem Cell (ADSC) in the affected joint. There was a surprising short term and long term improvement in pain control, mobility, and decrease in consumption of pain medication.
In the last 6 years approximately two thousand procedures have been completed in our institution, Stem Cell Miami, with an impressive record of safety and results.

We truly believe that in order for stem cell therapy to succeed and become the standard treatment before suffering through surgery, it needs to be standardized and understood by the medical community everywhere.
In order to have an impact in others we need to stay intact, meaning that we don’t give up our philosophy in Stem Cell practice and then make contact with others with our same interest. This is our mission and purpose, is to show our protocols, so that anyone that believes and sees our success can reproduce it. We want Stem Cell Therapy to be the medical revolution of XXI Century.

The Safety of Intra-Arterial Infusion of Autologous Adipose Derived Stem Cells (ADASC)

Abstract

Selection of the most effective administration route is a decisive step for the success of the cellular transplant therapy approach. Different routes are commonly used for the administration of stem cells to humans with relatively safety margins: Local injection, intra-articular injection, intra-parenchymal injection, and intravenous infusion. Local and intra-articular injection of stem cells are very effective because produce a significant increment of stem cells locally with relative safety. Intra-parenchymal injection of stem cells implies a significantly invasive method with little margin of safety and potential risk for complications. The intravenous route of infusion of stem cells is commonly used for cellular therapy with minimal risk for complications reported.

Stem cells are present in most tissues. Among the sources most commonly used we find adipose tissue, bone marrow, and peripheral blood. Other tissues yield a low count of viable stem cells, hence expansion and culture are necessary to increment the cell population to levels adequate to exert therapeutic effects. For the procedures related here, we exclusively used stem cells derived from adipose tissue isolated using a proprietary protocol and cell extraction medium.

A more effective route of administration and more reliable source of stem cells is needed to deliver autologous, non-cultured, minimally manipulated stem cells directly to target organs. The source tissue of stem cells should be one that yields a high count of cells ready to transplant within few hours after harvesting. With this setting in place, the harvesting of tissue, isolation of cells, and autologous transplant could be performed as a single procedure and within four hours.

Intra-arterial infusion of ADASC is a novel approach that provides an effective route for delivery of a higher count of stem cells directly into the target organ. This is an advanced therapeutic approach for different medical conditions affecting organs and limbs. The adipose tissue is an excellent source for stem cells. Harvesting adipose tissue is fast and easy, has low risk for complications, and tissue is readily and abundantly available. A larger amount of tissue harvested yields a significantly larger count of viable cells.

Harvesting adipose tissue is fast and easy, has low risk for complications, and tissue is readily and abundantly available. A larger amount of tissue harvested yields a significantly larger count of viable cells.

The effect of Autologous Activated Platelet Rich Plasma (AA-PRP) injection on pattern hair loss: Clinical and Histomorphometric evaluation

Introduction

Platelet-Rich Plasma (PRP) has emerged as a new treatment modality in regenerative plastic surgery, and preliminary evidence suggesting that it might have a beneficial role in hair growth. In addition, activated autologous platelet-rich plasma (AA-PRP) has been reported to foster the proliferation of dermal papilla cells.

Objectives

To investigate the safety and clinical efficacy of AA-PRP injections for pattern hair loss.

Patients and methods

AA-PRP, prepared from a small volume of blood (18 cc), was injected on half of the selected patients’ scalps with pattern hair loss. The other half was treated with placebo.

Three treatments were given for each patient, with intervals of 1 month. The endpoints were hair re-growth, hair dystrophy as measured by dermoscopy, burning or itching sensation, and cell proliferation as measured by Ki-67 evaluation. Patients were followed for 1 year.

Results

At the end of the 3 cycles of treatment, the patients presented clinical improvement in the mean number of hairs, with a mean increase of 18,0 hairs in the target area, and a mean increase in total hair density of 27,7 (number of hairs/cm2) compared with baseline values.

No side-effects were noted during treatment.

Microscopic evaluation showed the increase of epidermis thickness and of the number of hair follicles two weeks after the last AA-PRP treatment compared to baseline value (p<0.05).

We also observed an increase of Ki67+ keratinocytes of epidermis and of hair follicular bulge cells, and a slight increase of small blood vessels around hair follicles in the treated skin compared to baseline (p<0.05)

Conclusion

Our data clearly highlights the positive effects of AA-PRP injections on male pattern hair loss without major side-effects.

The application of Enhanced Stromal Vascular Fraction and Platelet-Rich Plasma Improves Fat Grafting Maintenance in Breast soft tissue defects

Abstract

The use of autologous fat grafting is ideal in breast reconstruction. However, published data on long-term outcomes and instrumental results of fat grafting to the breast are lacking.

The purpose of this study was to review the authors’ experience of fat grafting, evaluating the effects related to the use of enhanced stromal vascular fraction (e-SVF) and fat grafting with platelet-rich plasma (PRP) in the maintenance of fat volume in breast reconstruction, comparing the results with a control group.

Twenty-three patients aged 19–60 years affected by breast soft tissue defects were analyzed at the Plastic and Reconstructive Department of the University of Rome Tor Vergata. Ten patients were treated with SVF-enhanced autologous fat grafts, and 13 patients were treated with fat grafting + platelet-rich plasma.

The patients in the control group (n= 10) were treated with centrifuged fat grafting injection according to Coleman’s procedure. The patients treated with SVF-enhanced autologous fat grafts showed a 63% maintenance of the contour restoring and of three-dimensional volume after 1 year compared with the patients of the control group treated with centrifuged fat graft, who showed a 39% maintenance. In those patients who were treated with fat grafting and PRP, we observed a 69% maintenance of contour restoring and of three-dimensional volume after 1
year.

As reported, the use of either e-SVF or PRP mixed with fat grafting produced an improvement in maintenance of breast volume in patients affected by breast soft tissue defect.