Navigation Links
Personalized Stem Cells, Inc. Submits Investigational New Drug (IND) Application for the Treatment of Osteoarthritis with Stem Cells
Date:6/18/2019

Personalized Stem Cells, Inc (“PSC”), a human adipose-derived stem cell company, has submitted an Investigational New Drug (IND) application to the FDA for use of a person’s own adipose-derived stem cells to treat their osteoarthritis. The first clinical trial uses stem cells as a treatment of osteoarthritis in the knee. This IND is the first of several planned clinical trials which will enable qualified PSC-enrolled physicians to provide FDA compliant, regulated quality cell therapy to patients suffering from osteoarthritis. PSC plans to conduct a series of FDA-IND approved clinical trials starting with uses in orthopedics and expanding to other medical conditions in the future.

PSC has contracted with VetStem Biopharma for cGMP stem cell manufacturing for use in Phase I/II human trials by the PSC network of physicians. PSC has also licensed the VetStem patent portfolio and intellectual property for use of adipose-derived regenerative cells.

The current environment of in-office, unregulated manufacturing of stem cells by physicians has come under serious regulatory action by the FDA, FTC, and the Federation of State Medical Boards. It is clear that the only allowed use of stem cells will be through legitimate FDA clinical trials with manufacturing in a controlled FDA inspected, GMP compliant facility. Qualified physicians enrolled in the PSC network will have access to quality manufactured, safety tested cells for use in FDA approved clinical trials. They will also be able to share their experiences with other PSC network physicians in order to better define and implement the highest quality treatment options in the future.

PSC was founded by Robert Harman, DVM, MPVM and Michael Dale, both of whom also co-founded VetStem and are both experienced serial entrepreneurs.

“This is a unique opportunity in history to have a profound influence on the development and adoption of a game-changing medical technology,” says Mr. Dale. “Regenerative medicine may offer help for a wide array of conditions that are not effectively treated with today’s medicines.”

“We believe that we can jumpstart human stem cell therapy using the VetStem GMP manufacturing capabilities, extensive preclinical data, and experience. Mr. Dale will rapidly lead PSC forward with legitimate FDA approved clinical trials,” says Dr. Harman.

About Personalized Stem Cells, Inc.
Personalized Stem Cells was formed in 2018 to advance and legitimize human regenerative medicine. This privately held biopharmaceutical enterprise, based near San Diego (California), offers qualified physicians who enroll, an FDA compliant autologous stem cell product (from patient’s own fat tissue) for use in FDA approved clinical trials. PSC is driving development and adoption of stem cell and regenerative medicine within the FDA-IND process by providing quality manufactured, safety tested cells, and well-defined clinical trials. PSC has licensed a portfolio of over 70 issued patents in the field of regenerative medicine.

Read the full story at https://www.prweb.com/releases/personalized_stem_cells_inc_submits_investigational_new_drug_ind_application_for_the_treatment_of_osteoarthritis_with_stem_cells/prweb16384983.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related biology technology :

1. VetStem Biopharma, Parent Company of Personalized Stem Cells, is Approved for Stem Cell Manufacturing by the California Department of Public Health
2. A New Kind of Thinking Cap: Worcester Polytechnic Institute Researchers Are Using Brain Imaging to Improve Personalized Learning Environments
3. RSNA: Personalized Treatment Benefits Kidney Cancer Patients
4. PhysIQ Personalized Physiology Analytics (PPA) Wins DPharm Idol 2017
5. Director of Scientific Programs of NIH’s All of Us Research Program to Provide Update at the 9th Annual Personalized & Precision Medicine Conference
6. ACEA Biosciences Announces Collaboration with Memorial Sloan Kettering Cancer Center on Personalized CAR T Cell Therapy
7. ISABS: Personalized Medicine Conference With Nobel Prize Laureates Participation to be Held in Dubrovnik, Croatia
8. Notable Labs Enters into a Collaboration Agreement with IntelliCyt to Develop a Phenotypic Personalized Medicine Platform for Cancer Patients
9. Proove Health Foundation Is Created to Support the Role of Personalized Medicine in Public Health Epidemics
10. IntelliCyt and FIMM Announce a Collaboration to Advance Personalized Medicine in Cancer Treatment
11. Proove Biosciences Highlights Personalized Medicine Technology as an Approach to Reduce Prescription Drug Abuse
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/11/2019)... CONSHOHOCKEN, Pa. (PRWEB) , ... September 09, 2019 ... ... Interactive Response Technology (IRT) for clinical trial randomization and drug supply chain management, ... software provider for the global life sciences industry. , “The integration between Veeva ...
(Date:9/9/2019)... (PRWEB) , ... September 09, 2019 , ... Visikol CEO ... that was focused on how best to characterize 3D cell culture models. The ... that they are too thick and opaque to image through and therefore traditional wide-field ...
(Date:9/4/2019)... SOMERSET, N.J. (PRWEB) , ... ... ... leading global provider of advanced delivery technologies, development, and manufacturing solutions for ... Harris, Ph.D., Director, Science & Technology will present at the upcoming Nordic ...
(Date:8/29/2019)... (PRWEB) , ... August 28, 2019 , ... ... and wide-ranging DuPont™ Danisco® ingredient solutions to attendees at the International Baking Industry ... solve today’s baking challenges from optimizing production efficiency to cost and waste reduction ...
Breaking Biology Technology:
(Date:8/19/2019)... ... August 19, 2019 , ... ... the use of ultra-thin two dimensional slices which are placed on microscope slides, ... for complex tissues and complicated features such as vasculature and thus researchers in ...
(Date:8/14/2019)... ... August 14, 2019 , ... An upcoming episode of Advancements ... therapeutics are helping to promote normal immune function in order to prevent and ... about the DECODE.DESIGN.CURE™ technology platform, which rapidly develops microbiome therapeutics in order to ...
(Date:8/14/2019)... Calif. (PRWEB) , ... August 14, 2019 , ... ... into their future children, announces inclusion in the 38th annual Inc. 500|5000 list ... eligible to apply. To qualify, companies must have been founded and generating revenue by ...
Breaking Biology News(10 mins):