Jointechlabs launches European expansion with new partnerships, grants, and subsidiary

European focus includes a new subsidiary in Austria, a medical research center in partnership with a prominent health center, and development and distribution agreements for Germany, Austria, Switzerland, Italy, Spain, and the Balkans.

CHICAGO, OCT. 20, 2022/PRNewswire/–Jointechlabs, Inc., a Regenerative Medicine Solutions company announced a Vienna-based subsidiary named JointechPlus GmbH. They also announced research, development, and clinical partnerships with Laakirchner Gesundheitszentrum (LGZ), a multispecialty health center in Upper Austria, and Educell, a Slovenian biotech company.  New distribution partners include R.E.N.G. GmbH and Eywa S.r.l., while a new grant has been secured from the Slovenian government.

JointechPlus

“JointechPlus (http://www.jointechplus.at/) allows us to develop and market products for and in cooperation with the European community,” said Dr. Nathan Katz, CEO of Jointechlabs.  “We are thrilled to welcome our European partners and investors in our drive to bring regenerative medicine solutions to Europe and the world,” said Dr. Nishit Pancholi, COO of Jointechlabs.

Research, Development, and Clinical Partnerships

JointechPlus has formed a partnership with LGZ (https://www.lgz.co.at/) to establish a medical research center that will be the hub for regenerative medicine solutions, focusing on orthopedic and wound healing therapeutic biologics.

Mr. Christian F. Albrecht, Managing Director at LGZ, said “Our partnership with JointechPlus allows us to bring advanced regenerative medicine solutions to our patients, while expanding our ability to educate and train medical professionals in this fast-growing field.”

Slovenia-based Educell (https:/www.educell.si/en/) has expertise in adipose-derived stem cells, and an extensive clinical network in the Balkans.  The partnership has secured a grant from the Slovenian government, positioning Jointechlabs and Educell to be the leaders in point-of-care adipose-based solutions in the Balkans.

Distribution Partnerships

The distribution agreements focus on Jointechlabs’ adipose processing systems MiniTC® and Mini-Stem System®.  The R.E.N.G. GmbH agreement covers Germany, Austria, and Switzerland, while the agreement with Eywa S.r.l. covers Italy and Spain.

About Jointechlabs

Headquartered in Chicago, IL, privately-held Jointechlabs is an emerging worldwide leader in regenerative medicine, enabling healthcare practitioners to provide safe, cost-effective, non-surgical regenerative medicine therapies at the point of care without change in infrastructure.

FDA-cleared MiniTC® is a stand-alone device for processing autologous fat into regenerative-cell-rich Microfat for a variety of orthopedic, aesthetic, wound healing, and reconstructive surgery applications. Outside the US, CE-Mark-pending Mini-Stem System® extracts Microfat and Stromal Vascular Fraction.

The pipeline includes the development of stem-cell-based therapeutics with 3D Bioprinted constructs and injectable stem-cell scaffolding.

More information at www.jointechlabs.com and www.linkedin.com/company/jointechlabs.
Contact: info@jointechlabs.com.

Jointechlabs is Granted Additional Patent for Innovations Using Adipose in Regenerative Medicine Applications

Chicago, Ill, October 3, 2022/ — Jointechlabs, a global leader in point-of-care regenerative medicine, was issued US Patent No. 11,447,748, “Encapsulated Adipose-Derived Stem Cells, Methods for Preparation and Therapeutic Use,” the third utility patent in a family of patents, securing the intellectual property portfolio towards planned development steps.

Jointechlabs’ unique technology is designed to enable health practitioners worldwide to utilize autologous adipose tissue and its derivates (a person’s own fat) for joint pain relief and a wide variety of orthopedic, aesthetic, wound healing, and reconstructive surgery applications.

“Innovation is a cornerstone of our success and strategy as a pioneer and leader of the regenerative medicine industry,” said Dr. Nathan Katz, CEO of Jointechlabs. “This patent strengths the IP basis of our therapeutic development leveraging the already commercially available MiniTC® and Mini-Stem System® platform family. Securing a solid IP portfolio demonstrates both our commitment to innovation and our ability to secure patent protection in a way that strengthens our leadership and our competitive advantage.”

This latest patent covers methods and systems of encapsulating mesenchymal stem cells in a three-dimensional biocompatible gel matrix, maintaining the viability and location of the stem cells for an extended period, a significant advantage for therapeutic treatment efficacy as compared to stem cells in suspension.

Jointechlabs has a portfolio of 12 US and foreign patents. The latest patent joins the family that includes US Patent Nos 9,931,445, 9,938,501, and 10,745,666, issued between 2018 and 2020, with 11,447,748 extending coverage through 2032. Other patents have been granted in China, EU, Israel, Japan, and Ukraine.

Dr. Nishit Pancholi, COO of Jointechlabs added “We are gratified to have earned this latest patent, further memorializing our innovation, which continues to be validated by the global marketplace success of our products.”

About Jointechlabs

Headquartered in Chicago, IL, privately-held Jointechlabs is an emerging worldwide leader in point-of-care regenerative medicine, enabling healthcare practitioners and hospitals provide safe, cost-effective, non-surgical regenerative medicine therapies at the point-of-care without change in infrastructure.
FDA-cleared MiniTC® for the US market is a stand-alone device for processing autologous fat into regenerative-cell-rich Microfat for a variety of orthopedic, aesthetic, wound healing, and reconstructive surgery applications. Outside the US, CE-Mark-pending Mini-Stem System® prepares Microfat and also extracts Stromal Vascular Fraction.
Pipeline products include stem-cell therapeutics such as Bioprinting and injectable stem cell scaffolding.
More information at www.jointechlabs.com and www.linkedin.com/company/jointechlabs.
Contact: info@jointechlabs.com.

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Jointechlabs’ MiniTC Training by Dr. Nathan Katz, Ph.D., and Dr. Enrico Guarino

Jointechlabs is an emerging leader in the field of outpatient autologous regenerative and rejuvenating therapies.

The recent commercial launch of the MiniTC® device is causing disruptive waves across the industry. This unique sleekly designed disposable and multifunctional product offers uncomparable simplicity, convenience, and quality altogether. 

Jointechlabs genuinely integrates its technology into the existing workflows of healthcare providers, expanding treatment options and bringing the next generation of therapeutics down to everyday medical practice for the whole benefit of patients and communities.

Here is one of the most recent pieces of training for the application of MiniTC-manufactured microfat grafts in the Chicago area.

Guided Lymphangiogenesis for the Treatment of Lymphedema: Preliminary Clinical Results

Catarina Hadamitzky, Tatiana S. Zaitseva, Nathan Katz, Claire P Edelstein, Manuel T. Escarraman, Dung Nguyen, Michael V. Paukshto

Clinic of Plastic, Aesthetic and Hand Surgery, Helios Clinic, Hildesheim, Germany.

Fibralign Corporation, Union City, California, USA.

JointechLabs, Inc, N. Barrington, Illinois, USA.

Instituto Oncológico Dr. Heriberto Pieter, Santo Domingo, Dominican Republic.

Department of Plastic Surgery, Stanford University, Stanford, California, USA.

To address the limitations of current treatments for secondary lymphedema, our study group developed an experimental surgical procedure based on Autologous Lymph Node Fragment (ALNF) transfer supplemented by nanofibrillar collagen scaffold with and without autologous Adipose-Derived Stromal Cells out from the stromal vascular fraction (ADSCs). The efficacy of this scaffold was demonstrated before in a porcine model of secondary lymphedema. To address the challenges of poor survival and low migration from the injection site described in clinical studies of ADSCs, we used ADSC-seeded scaffolds to deliver the cells. These scaffolds seem to support cell survival, maintenance, and function at the targeted site. The ongoing pilot study has 12 patients currently enrolled. We used non-vascularized autologous lymph node fragment transfer (LNFT) as a basic treatment for all patients. It was supplemented by implantation of: BioBridge scaffolds (n=5); BioBridge scaffolds with ADSCs (n=2); BioBridge scaffolds with injected ADSCs (n=1); and injected ADSCs only (n=4; control group still ongoing). In the therapy groups, no complications have been reported after almost one year. 6 of 8 patients using BioBridge responded to the treatment after 6 months with an average volume reduction of about 20%. Two of these patients have attained a normal limb volume ratio (≤1.1) at 3 months after surgery. The average edema reduction in the control group (n=4) was only 1.1% 4 months after surgery. More data will be presented at the time of the conference. While vascularized lymph node transfer is considered to be a more advanced technique than ALNF transfer, there is a great interest in developing countries to have simpler surgery to manage lymphedema without the need for a microscope. On the other hand, the concept of guiding lymphangiogenesis with collagen scaffolds could also potentially improve the efficiency of well-established vascularized lymph node procedures.

3D Bioprinting of Autologous Adipose Tissue for Wound Healing

Critical skin wounds are a major cost for the health sector and lead to immense suffering for the patients. One way to facilitate the healing of these wounds is through autologous adipose tissue transplants. However, the implanted tissue needs to be vascularized or it will suffer from necrosis. To combat this Stromal vascular fraction (SVF), which is isolated from fat, can be utilized as it has been shown to promote both vascularization and the wound healing process. In this project, we evaluate a method that combines SVF with 3D Bioprinting to create thick fat grafts for in situ vascularization.

METHODS:

Adipose tissue was taken with consent from patients undergoing plastic surgery and was isolated with MiniStem, the device from JoinTechLabs, USA. Two MiniStem protocols were run: (i) lipoaspirate was fractured toward macerated fat graft and (ii) lipoaspirate was enzymatically treated in order for SVF harvest. Collected SVF was analyzed with FACS. Both fractions were mixed with a hydrogel composed of a mix of nanocellulose and alginate. The resulting cell-laden hydrogels (bioinks) were 3D Bioprinted as gridded constructs with CELLINKs INKREDIBLE+ bioprinter. The properties of the final constructs and bioinks were evaluated from a rheological perspective using a rheometer and O-prints, a method developed in-house.

RESULTS:

The o-print showed that the mixed hydrogels were homogenous and easily printable. Rheology testing revealed that the crosslinked bioink also displayed properties like that of the extracellular matrix. FACS of the extracted SVF fractions showed the presence of a heterogeneous cell population with a substantial presence of ASCs, pericytes, and endothelial progenitors.

FACS data for SVF  isolated with Ministem

DISCUSSION & CONCLUSIONS: 

We have shown that we can isolate both fat and SVF from the same liposuction procedure. These results also show that fat and SVF isolated with the MiniStem and mixed with biopolymers contain relevant cells and possess good printability. High expression of angiogenic markers in both protocols strongly indicates potential angiogenic capacity.

Nanofibrillar Scaffold with Plated Adipose-Derived Stem Cells, Its Use for Lymphedema Treatment in Rats, and Path for Clinical Application

Gloria Sue, Dung Nguyen, Dimitris Dionysiou, Tatiana Zaitseva, Cristhian Montenegro, Peter Tabada, Peter Deptula, Derrick Wan, Nathan Katz, Michael Paukshto, Stanley Rockson.

Stanford University, Stanford, CA, US

Aristotle University of Thessaloniki, Greece

Fibralign Corp, Union City, CA, US 

Jointechlabs, San Francisco, CA, US

To address the current deficit of sustainable lymphedema treatment, we investigated lymphatic regeneration guided by thread-like aligned nanofibrillar collagen scaffolds (BioBridge), which facilitate cell attachment, alignment, and migration. In this study, we tested our hypothesis that implantation of BioBridge with seeded Adipose-Derived Stem Cells (ADSCs) can reduce lymphedema when used in animals with developed lymphedema.

The rat lymphedema model involved inguinal and popliteal lymphadenectomy followed by irradiation. Subjects that developed lymphedema one month after lymphadenectomy/irradiation either received implantation of BioBridge with allogeneic ADSCs (treatment group) or remain untreated (control group). All subjects were observed for 4 months after lymphadenectomy.  The change in affected to unaffected limb volume ratio was evaluated using CT-based volumetric analysis. Lymph flow and lymphangiogenesis were also assessed by ICG.

Subjects in the treatment group showed a reduction in affected limb volume (affected/non-affected limb volume ratio decreased from 113% to 97% (p <0.02)). ICG fluoroscopy demonstrated lymph flow and formation of lymphatics towards the contralateral groin in the direction of the implanted scaffolds. Conducted immunogistohistology supported the findings.

These data show that in the rat lymphedema model, the treatment of established lymphedema with BioBridge and ADSC substantially reduces lymphedema.

In preparation for a clinical application, we characterized human ADSC plated on BioBridge by FACS and compared manual ADSC isolation protocol with isolation using MiniStem system which is suitable for use in a clinical setting. 

Combining Freshly Isolated Adipose-derived Cells With Regenogel-OSP

Nathan Katz, MSc, Ph.D., Jointechlabs, Inc., USA
Avner Yayun, MD, Ph.D., Procore Biomed, Israel

Procore Biomed has developed a hyaluronic-acid – plasma cross-linked hydrogel “RegenoGel” suitable for the growth and differentiation of skeletal tissue stem and progenitor cells.

Jointechlabs has provided adipose-derived cell fraction obtained by the “Mini-Stem System”, which contains a range of 2-8% of mesenchymal stem cells with a potential chondroprotective effect on the joints in patients suffering from Knee OA.

Procore tested several parameters for the growth and differentiation of these cells when embedded in Regenogel OSP-based hydrogels. The hydrogels were prepared using the patient’s own autologous plasma linked to Regenogel-OSP-activated HA. Approximately 1 million cells (corresponding to approximately 40-50,000 MSCs) were mixed with the conjugate in loose-cap 5 ml falcon tubes and embedded within the hydrogel by the addition of Thrombin (approximately 0.25 IU/gel). 2 hrs later growth medium (1 ml; DMEM: F12) was added on top of the hydrogel and the tubes were placed in a 5% CO2 Incubator for different time points.

The integrity of the hydrogel was monitored by visual inspection of the intact hydrogel over time. Survival and proliferation of the cells were monitored using the metabolic dye Alamar blue. Cell differentiation was monitored using a functional ELISA for the presence of VEGF in the culture medium. Chondrogenic differentiation was monitored by measuring soluble glucosaminoglycans (sGAG). The effect of the proliferation and differentiation of these cells within the hydrogel was monitored with or without the addition of 10ng/ml of FGF2 twice weekly as a positive control for MSCs survival and proliferation.

Results:

The differentiation and proliferation of ADCs in Procore’s Regenogel-OSP. A. Proliferation is delayed without FGF2 but reaches similar levels after approximately two weeks. B. VEGF signal begins to rise after approximately one week in culture in the presence of FGF2, and after 12 days in the absence of FGF2, reaching similar levels at 15 days in culture. C. Soluble Glucosaminoglycans (sGAG) increase parallels VEGF and Alamar Blue signal increase.

Conclusions:

Hydrogel integrity: All hydrogels remained fully intact after 15 days in culture, and displayed no signs of degradation.

Cell survival and proliferation: There was excellent survival and proliferation of the cells both with and without FGF2. FGF2 moderately accelerated the proliferation at initial time points (approximately one week in culture).

Secretion of VEGF: VEGF as a major angiogenic stimulator is largely secreted by mesenchymal stem cells (MSCs), and serves as a marker for MSC potency. A sharp increase in VEGF levels produced by the embedded cells indicates good survival and retention of active MSCs within the hydrogel for at least 15 days.

Chondrogenic differentiation: soluble glucosaminoglycans are secreted into the medium by differentiating chondrogenic cells. Indeed, a sharp rise beginning after one week in culture was detected.

We continue to follow up on the integrity, survival, and differentiation of MSCs in the Hydrogel over time.

Short Review: Non-cultured Adipose-derived MSCs for Treatment of OA, Jointechlabs, Inc.

Egg cells flowing in a blue background

Treating patients with OA presents a significant challenge for physicians as no therapies to date have demonstrated efficacy in curing or even halting disease progression. Therefore, most approaches initially target pain management and factors that may be exacerbating stress on the joint.

https://dx.doi.org/10.2147%2FSCCAA.S68073 – Mayo Clinic, MN

Corticosteroid toxicity for chondrocytes has been long reported, both for cartilage and tendons :
– https://www.ncbi.nlm.nih.gov/pubmed/15885481 ;
– https://www.ncbi.nlm.nih.gov/pubmed/22886634.

The efficacy of arthroscopic procedures are extensively debated since the study published in 2002 in The New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa013259). The complete inefficiency was confirmed by the most recent randomized controlled study published in 2017:
https://www.ncbi.nlm.nih.gov/pubmed/28678120

MSCs could provide an ideal source for direct regeneration of joint surfaces. While stem cells can both differentiate into new cartilage cells as well as suppress inflammation, recent studies have found that stem cells can also combat OA through paracrine mechanisms. They release important cytokines such as epidermal growth factor (EGF), transforming growth factor beta (TGFB), vascular endothelial growth factor (VEGF), as well as other cytokines and new cartilage proteins that are essential in combating OA and degenerative processes. It has also been suggested that stem cells could release cytokines and proteins that could help combat neurogenic pain, which would have numerous benefits in treating OA pain :
– https://www.ncbi.nlm.nih.gov/pubmed/23881068 ;
– https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4880954/ ;
– https://www.ncbi.nlm.nih.gov/pubmed/25512139 .

Regeneration of joint tissues has been documented after injection of MSCs; however, some studies have found that reconstitution of tissue is primarily from native cells and relatively few transplanted cells :
https://www.ncbi.nlm.nih.gov/pubmed/14673997

Other studies have shown that the cell signaling milieu is altered after the administration of MSCs with a subsequent increase in Type II collagen production by the host (https://www.ncbi.nlm.nih.gov/pubmed/22750747). Together, these factors suggest that MSCs may be orchestrating the reparative response rather than directly replacing damaged areas. This is in line with the well-documented anti-inflammatory and immunomodulatory role of MSCs (https://www.ncbi.nlm.nih.gov/pubmed/25426250). One of the breakthrough studies recently published has clearly demonstrated the attachment of MSCs to the full-thickness cartilage defects in rat models. Furthermore, these cells were found in abundance in the defect area 28 days after injection. What is intriguing is that the cells did not participate directly in the regeneration of the host cartilage in the long run since no tracking markers were observed 6 months following the injection.
The study concluded that MSCs did not give rise to new chondrocytes for long-term regeneration and the paracrine effect played a major role in the recruitment of the host regenerative capabilities (https://insight.jci.org/articles/view/87322).

Adipose stem cells/adipose-derived stromal cells (ASCs) have gained attention due to their abundance, excellent proliferative potential, and minimal morbidity during harvest. Adipose-derived mesenchymal stem cells (ADSCs) can be harvested from the patient’s own adipose tissue via surgical liposuction. These advantages lower the cost of cell therapy by alleviating the time-consuming procedure of culture expansion :
https://www.ncbi.nlm.nih.gov/pubmed/?term=Fulzele%20S%5BAuthor%5D&cauthor=true&cauthor_uid=27510262

ADSC therapy for OA in animal studies is well documented (https://www.ncbi.nlm.nih.gov/pubmed/26987846). Toghraie et al. demonstrated that ADSCs derived from IFPs in rabbits given to rabbits with OA-induced knees had less cartilage destruction, less subchondral sclerosis, less osteophyte buildup, as well as better cartilage overall than the control group (https://www.ncbi.nlm.nih.gov/pubmed/20591677). It also was demonstrated that autologous ADSC therapy decreased the progression of degeneration in cartilage and in the synovial membrane, improving meniscal repair. The regenerative effect of autologous ADSCs is dose and time-dependent (https://www.ncbi.nlm.nih.gov/pubmed/23360790). Another group also reported cartilage regeneration following autologous ADSC therapy in a surgically induced osteoarthritic sheep model. Autologous ADSCs were labeled and intra-articularly injected, leading to the cells populating the area of damaged cartilage as well as a decreased progression of OA : https://www.ncbi.nlm.nih.gov/pubmed/24911365

Several clinical studies also prove ADSCs’ efficacy in treating OA in human patients. Koh et al. treated patients with knee OA undergoing arthroscopic debridement with injected autologous ADSCs derived from IFPs and prepared in platelet-rich plasma (PRP). Treated patients demonstrated improved mobility and function in the affected knees, reduced pain levels, and better clinical prognoses in a 1-year follow-up:
https://www.ncbi.nlm.nih.gov/pubmed/22583627

Some authors found the patients had significantly improved Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scores, VAS pain scores, and cartilage regeneration as confirmed by MRI following 2 years of follow-up: https://www.ncbi.nlm.nih.gov/pubmed/23375182

In a different proof-of-concept clinical trial, autologous ADSCs were injected in patients with knee OA. The high-dose injection group had increased WOMAC scores 6 months after injections, decreased cartilage defects in affected areas, and increased cartilage volumes with thick, hyaline cartilage-like regeneration (https://www.ncbi.nlm.nih.gov/pubmed/24449146).

In 2011, Pak demonstrated the potential of ADSCs in osteonecrosis of the hip and OA in the knees of several patients. Results revealed bone formation in the osteonecrosis patients as well as cartilage regeneration in the OA knee patients. These patients’ MRIs had increased meniscus cartilage volume and thickness due to the ADSCs injections (https://www.ncbi.nlm.nih.gov/pubmed/21736710).

These results further proved the promising efficacy of autologous ADSCs in treating OA in humans, as well as demonstrated its safety as there were no adverse events. More similar clinical trials are necessary to further prove ADSCs’ efficacy for routine use in the human OA setting and more precisely define the mechanism of action. Last, but not least, it has been very recently documented that stem cells help dying or damaged cells by “recharging their mitochondrial batteries” in different organs, including joints:
– https://www.ncbi.nlm.nih.gov/pubmed/24431222;
– https://peerj.com/articles/3468/ .

In a degenerative joint, the mitochondria have been extensively exhausted and this reduces the functionality of cells. Healthy stem cells that have been injected into the affected joint, can rejuvenate damaged cells by transferring their “fully charged” mitochondrial batteries into the damaged cells. This final step completes a cascade of events that take place in the osteoarthritic joint (http://docplayer.net/21035327-Role-of-mitochondria-in-mesenchymal-stem-cells.html). The inactivation of the macrophages and the secretion of “helper” growth factors explain the long-term anti-inflammatory effect seen particularly with a stromal vascular fraction (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3296619/). This mechanism of action shows how stem cells may decrease pain and swelling. The above model also suggests that stem cells have a disease-modifying effect, by restoring the balance of cells within the joint: there is an increase in the number of “facilitating” stem cells and a decrease in the number of “destructive” macrophages, reducing this way the self-destruction of the joint.

For proprietary information, use, contact Dr. Nathan Katz at email:
nathan.katz@jointechlabs.com

Comparison of Different Conditions for the Survival of Human Abdominal Fat in vitro

Katz, N., Koukharenko, V. and Geldner, P2,3.

Laboratory of Stem cells and Bioengineering, Jointechlabs, Inc., Skokie, IL

North Michigan Surgical Center, Chicago, IL

Geldner Center, Chicago, IL

Introduction:

Fat auto graft transplantation method for different reconstructive plastic surgeries has been fueled recently by encouraging reports from Japan, the United Kingdom, the United States, and others. Hundreds of performed procedures around the world didn’t confirm the major concern of inducing malignant transformation upon fat transplantation. Based on these reports American Association of Plastic Surgeons has removed restrictions on this kind of treatment. However, the efficacy of the method remains to be improved due to the low survival of fat tissue upon transplantation of large auto grafts, particularly in breast reconstructive and augmentation surgeries.

We assume that adding purified autologous adipose-derived mesenchymal stem cells (ADMSC) could improve the survival of fat transplants. 

Vascular Endothelium Gross Factor (VEGF) persists in the human body, including fat tissue, and participates in the induction of endothelium formation and vascular development. Nevertheless, we suggest that external supplements of VEGF could increase neo-vascular development thereby improving support for fat transplant. 

Previous reports on this subject are controversial and do not provide scientific evidence on the effect of MSCs and VEGF on fat viability.

We are aiming by this study to investigate the effect of human autologous ADMSCs and VEGF supplements on human adipose tissue viability in vitro. 

Study design:

Model: 3gr fat in 5ml DMEM, supplemented 7.5% FBS and Antibiotics 1X

Calculation of VEGF concentration

The final work concentration is 50ng/ml.  In order to prep 10ml of the working medium, we need 500ng, which is 0.5ug.

When reconstituting the original 20ug of VEGF in 1ml of distilled water, we achieve a concentration of 20ug/ml. Adding 9ml of DMEM (suppl. 7.5% FBS) brings to conc. 20ug/10ml or 2ug/ml.  0.25ml of this solution contains 0.5ug of VEGF, which is required for the prep of 10ml of the working solution.

We aliquot the final 10ml of diluted VEGF into 0.25ml aliquots and freeze in liquid nitrogen vapor at -1700C.

For each 10ml of required medium with 50ng/ml of VEGF we have to thaw 1 vial of 0.25ml aliquot and add to 9.75ml of work medium.

Calculation of MSCs concentration

We applied a concentration of 30.000 cells per 50ul of medium for each 1ml of fat.

The imitation of the proposed clinical concentration was calculated as follows:

We assumed that for 400ml of transplanted fat 20ml of MSCs suspension could be mixed in. Therefore for each 1ml of fat 50ul of cell suspension should be added.

We suggest based on our results that 12 million purified MSCs could be prepared for clinical application within a short time of lab culture (data not presented yet). Assuming that 12 mills of cells would be applied in 20ml of solution in case of clinical application, we calculated and prepared for the presented experiment 30.000 of MSCs per 50ul of medium for each 1ml of fat.

Our experiment contained 4 study groups:

Group #1: 3gr of fat in 5ml of work medium (see above) supplemented with 50ng/ml

VEGF and 90.000 MSCs, suspended in 150ul of the same medium;

Group #2: 3gr of fat in 5ml of medium supplemented with 50ng/ml VEGF without MSCs supplement;

Group #3: 3gr of fat in 5ml of medium without VEGF supplementation but with the same amount of MScs as in the first group;

And Group #4: control – 3gr of fat in 5ml of medium without any of the above supplements.

In the current study, we used donor MSCs obtained in advance from fat tissue following 

clinical liposuction. Informed consent has been signed and the procedure approved by IRB.

Fat digestion and MSCs extraction were performed as described elsewhere.

All samples were cultured in 12cmflasks in an incubator at 370C and 5.5% CO2. 3ml of the appropriate medium was exchanged for a fresh one every three days.

On day 14 and day 21 the free oil was measured as an indicator for degenerated lipocytes.

On day 21 the remaining fat was fixed and embedded in paraffin blocks for histological analysis of markers, specific for endothelial cells.

Results

Our preliminary results indicated significant development of neovascular network in the fat graft following MSCs enrichment. However, VEGF alone did not provide a measurable increase in endothelial expression. The total volume of remaining fat graft in groups 1 and 3 was almost twice more than in the control. Even though the volume of the survived fat graft in group 2 exceeded the control, the observed fat quality and appearance were incomparably worse than in MSCs containing groups 1 and 3.

Conclusion

Further investigation is required toward the scientific significance of the results.

Nevertheless, preliminary results confirm the feasibility of adipose-derived mesenchymal stem cells for the improvement of fat graft survival.

We are aiming to expand the study forward application of non-purified cells, adipose-derived stromal vascular fraction, in terms of neo-vascularization of grafted tissues and organs.

Regenerative Medicine: The Field Has Come a Long Way and Now is Having its Moment

Jointechlabs Launches MiniTC for Point-of-Care Fat Tissue Processing

The scientific community has regarded regeneration as a topic of interest for thousands of years. Long before it was dubbed ‘Regenerative Medicine’, this type of medical intervention was applauded by healthcare professionals for its successful outcomes. Early discoveries, such as skin graft procedures for facial reconstructions, have greatly influenced the field as we know it today.

Following a long history of enthusiasm, researchers however began to question the integrity of the procedures being performed, specifically, the tissues being transplanted, and began wondering whether it was possible to create, grow, and harvest these tissues in the laboratory. Thus began the era of ‘Tissue Engineering. Fast forward to today, regenerative medicine is regarded as a major advancement in medical treatment, based on the principles of stem cell technology and tissue engineering, designed to replace or regenerate human tissues and organs and restore their functions.

Recently, Jointechlabs (JTL) received FDA clearance in the US for its device, MiniTCTM, for point-of-care fat tissue processing designed to obtain microfat for multiple indications. MiniTC is a disposable, closed-loop medical device that can be used in the clinic setting, with no change in infrastructure, eliminating the need for manual processing of fat tissue in the lab. JTL plans to focus on reaching healthcare practitioners in several specialties including plastic surgery, orthopedics, aesthetic practices, internal medicine (e.g., primary care physicians who handle aesthetics or orthopedic procedures) and wound healing.

The company’s primary medical devices, including those in development, can isolate cell-enriched microfat as well as stem cell fraction (SVF) from fat. JTL’s pipeline products are FDA approvable stem cell therapies based on its technology for indications with unmet medical needs.

As one of the founders of Jointechlabs, I’m excited by the field of regenerative medicine as the company’s comprehensive and proprietary technology provides a variety of tissue reconstruction and regeneration options, enabling healthcare practitioners – in medical centers, hospitals, and clinics – to provide safe, reliable and cost-effective cell enriched fat grafts at the point-of-care. The FDA clearance of MiniTC represents an important step forward in the regenerative medicine market as it’s less costly, cumbersome, and labor-intensive compared to what currently exists.

MiniTC is available via the company’s distributors/partners or for purchase by healthcare professionals directly from the company. Distributors that have signed on thus far include Febomed LLC, Confluence, Tristate Biologics, Biomedical Innovation, Institute of Regenerative Medicine, and Center for Regenerative Cell Medicine.

Pipeline Products Jointechlabs has an extensive development program. In addition to MiniTC, the company’s Mini-Stem – a patented, disposable, closed-loop medical device – is pending approval in Europe (and under investigation in other countries) for isolation of stem cell fraction (SVF) from fat. Mini-Stem will enable doctors to provide safe, reliable, cost-effective non-surgical stem cell treatments at the point of care. Mini-Stem will serve as a platform for cell therapies and is well poised to target the developing regenerative medicine market, unlike any of the current devices. Additionally, JTL is developing a proprietary stem cell-scaffold product as a biological therapy for osteoarthritis, for approval under the FDA’s fast-track program.

An experienced and respected emerging world leader in point-of-care regenerative medicine, Jointechlabs invites the healthcare/medical community, and patients, to learn more about its comprehensive and proprietary technology. For more details, including how to obtain the device and training-related questions, please visit https://jointechlabs.com/.