Specific Research Activities

  • Clinical Trials

    Broad, multi-center clinical trial/study execution capability.

  • Research and Publication

    Participate in innovative studies, publish results alongside peers.

  • Scientific Network

    Connect and cooperate with our global network of international clinician and scientific thought leaders.

FAQ

Are you able to coordinate multi-center studies/trials?

Yes. Along with others, we believe this can be a particularly efficient approach to many studies.   It offers the possibility of suitable regulatory environments, multiple centers for patient enrollment, animal as well as human trials, lower overall costs and a broader spectrum of scientific and clinical resources. However, successful management of multi-center studies/trials requires centralized study design, IRB initial approval and follow-up processes, efficient data-collection, financial controls, access to pre-qualified individuals and clinics/research centers and the ability to set and maintain timelines. These are all Regen Med capabilities.

We own the rights to a product in the regenerative medicine space which has not yet received marketing approval. How would we work with you specifically?

That depends on a number of factors, including (i) the jurisdiction(s) in, and indications for, which you are seeking approval; (ii) the nature of existing supporting clinical science; (iii) similar products for which approval has been obtained; (iv) the nature of the product drug, biologic, device; (v) status of manufacturing facility QR/GMP and similar approvals; (vii) the extent of your in-house scientific/medical capabilities; and (viii) other matters. An initial conversation or two can typically clarify the foregoing points, after which Regen Med can propose a specific plan of action, timeline and budget.

What are some of the indications for which studies/trials are likely to make sense in the area of regenerative medicine?

Some examples include: (i) alopecia treatments using micronized fat, or stromal vascular fraction (“SVF”), or PRP, or a combination; (ii) osteoarthritis treatments using PRP, adipose and/or SVF; (iii) avascular necrosis of the femoral head treatments utilizing bone marrow aspirate, cancellous bone derived SVF, adipose tissue derived SVF, or a combination; (iv) preservation of cell viability through use of specific cannulae in adipose extraction; (v) chronic pulmonary obstructive disease treatment using systemic SVF injections; (vi) radiation injury treatment utilizing micronized fat, or SVF, or fat grafts; (vii) renal indications; (viii) pre-, peri- and post- operative ultrasound imaging utilizing specific devices, and/or imaging software; (ix) treatment of various vascular, orthopedic or other conditions utilizing specific biological matrices or gels, together with specific HCT’s; (x) anti-aging treatments utilizing cell-assisted fat, or SVF alone; and many others.

A variety of devices and biologics, as well as large patient populations, are implicated in each of these therapeutic directions.

Latest Research

  • Bone Marrow Concentrate for Knee and Hip OA: One Year Follow Up

    Bone Marrow Concentrate for Knee and Hip OA: One Year Follow Up

    Presented at the annual CELLS | Musculoskeletal 2016 conference in Amsterdam. 

    Jose Miguel Catalán, M.D., Severiano Dos Anjos Vilaboa, Ph.D.

    This is a prospective interventional clinical study including 8 patients . For preparing the bone marrow concentrate a new disposable point-of-care medical device was used. The total nucleated cell count for each patient was measured and recorded as quality control

    Pre and post-operative clinical outcomes overtime included the lower extremity functional scale (LEFS) and visual analog scale (VAS), as well as, MRI and Rx imaging during at least 6 months (ranging from 6 to 12 months). Download the abstract by clicking here: CELLS_Abstract_BMC_Catalan

    Read more →
  • The Potential Of Adipose-Derived Stem Cells in Orthopedics

    Mesenchymal stem cells (MSCs) are pluripotent cells found in numerous human tissues, including bone marrow and adipose. Such MSCs have been shown to differentiate into bone and cartilage, along with other types of tissues.

    Read more →