Hematopoietic Stem Cells
What are Hematopoietic stem cells?
Hematopoietic stem cells (HSCs) are cells that are found mainly in bone marrow, and cord blood which can grow into various different blood cells, such as red blood cells (erythrocytes), white blood cells (leukocytes) and platelets, and may be said to be the very source of blood. In addition, HSCs have the property of replicating themselves, and it is this that enables them to continuously produce blood.
What to expect ?
Trusted
1. Registered and regulated by the Food and Drug Administration (FDA).
2. Follows the highest standards established for cord blood banking.
- 1. National Marrow Donor Program® (NMDP)
- 2. World Marrow Donor Association® (WMDA)
- 3. Association for the Advancement of Blood & Biotherapies (AABB)
- 3. Licensed in all states that require a license.
- 4 .Approved for collections in all 50 US states.
Safer Transplants
1. We have released over 2,200 units
for transplant, research and clinical trials.
2.Fewer red blood cells means, safer transplants.
3. Our process removes 98.5% ofthe red blood cells
versus 33.45% by ourcompetitors.
More Stem Cells
1. Our proprietary processrecovers.
2. About 35% more stem cells than our
competitors.
Results
1. Our product(s) have been successfully trans
planted in thousands of patients through clinical trials, and for therapies.
2. Existing distribution channels for therapies and clinical research have yielded success.
3. Clinical accomplishments and advocacy led by leading surgeons and clinics.
4. Our process excels in clonogenic potential, resulting in superior therapeutic outcomes.
5. CFL productrecovers more T Cells,
B Cells, and HSCs.
Our Processing System
Our processing system is used to isolate the greatest amount of stem cells from umbilical cord blood.
1. The process is the most flexible cord-blood processing method, offering several special benefits and advantages over other processing methods.
2. The end result includes a reduction in the time to neutrophil engraftment.
3. It yields the highest number of colony-forming units (CFUs), which is currently the most accurate measurement to determine stem cell potency and the potential for stem cell engraftment.
4.It recovers the greatest percentage of CD34+ stem cells from human umbilical cord blood.
5. This processing type ensures that TNC and CD 34+ recovery is not affected by the initial volume of the collected unit.
6. It provides the greatest reduction in red blood cell (RBC) contamination compared with all other processing methods.
7. Processed samples have a significantly greater clonogenic potential than all current methods.
CTD Processing System
Better Treatment Outcomes
1. The result of the differences between processing methods has been shown to lead to better treatment outcomes.
2. With this processing method, processed cord blood units engraft more quickly than any other methods.
3. In an evaluation of the probability of and the time to patient neutrophil recovery by the St. Louis Cord Blood Bank, this processing had a median time of 16 days compared with 20 days for the Hespan group.
4. "After infusion of a single HES unit, 89% of patients achieved engraftment in 23 days (median 20). … After receiving a single processed unit, 91% of patients achieved engraftment in 18.6 days (median 16)."
5. Additionally, when the data on engraftment times from a number of public data sources were compared, this processing was found to engraft more quickly than all other cord blood–processing methods.
STABILITY EFFICACY PURITY
Our Product
It has an extensive track record for stability, efficacy
and purity.
Our product is evaluated using parameters deemed gold
standard to a potential mechanism of action;
✓ Total Nucleated Cell Count,
✓ Cell Viability,
✓ Sterility,
✓ Concentration of proteins,
✓ VEGF – a signaling protein for angiogenesis.
✓ IL-1Ra - a natural anti-inflammatory protein.
Our PREMIERMAX® product line
CFL PREMIERMAX®-Cord Blood Stem Cell-National Registry (25 mL/cc per bag)
Average TNC – 1 Billion (Ranges from 850M to 1.5B)
CFL-Cord Blood Stem Cell-World Registry (25 mL/cc per bag)
Average TNC – 725 Million (Ranges from 550M to 950M)
PREMIERMAXCB ®
is a newly developed biological therapeutic derived from
umbilical cord blood having too few cells for a full body transplant. The lower cell
count makes the PREMIERMAXCB ® product line perfect for smaller, localized
treatments. Each vial of PREMIERMAXCB ® contains 1mL/1cc of a cellular and
protein cocktail that has demonstrated remarkable results in early research testing.
PREMIERMAXCB ® comes in 3 doses, each 1mL/cc:
1. Silver (an average of 8 Million total nucleated cells)
2.Gold (an average of 15 Million total nucleated cells), and
3.Platinum (an average of 30 Million total nucleated cells), to allow the clinician
to tailor their treatment protocol.
Manufactured under cGMP conditions in our state-of-the-art clean room facility,
PREMIERMAXCB ® is tested to the highest standards for safety, quality, identity,
purity, and potency.
Stability Reports
Surface Markers
Sterility Testing
White Paper
White Paper ctd
Potential Uses- 25 cc bagged Products
✓ Over 80 approved IND’s via the NMDP.
✓ Newest and cutting-edge technologies are now available through CFL
partnership -
✓ For development of next-generation cell therapy products.
✓ Extraction of Exosomesfrom currently stored Cord Blood Stem
Cell units.
✓ Extraction of NK cells, T Cells, B Cellsfrom currently stored Cord
Blood Stem Cell units.
✓ Expansion of existing CB stem cellsinto larger quantitiesto help
in the treatment of cancers, etc.
Potential Uses 1 cc Vialed Products
✓ The only minimally manipulated cord blood product that has received FDA approval of an Investigational New Drug (IND) Application for a Phase 1a, open label, dose ranging study to assess the safety, tolerability, preliminary efficacy, and dose effect of its umbilical CB derived stem cell product in patients with lower back pain of the Sacroiliac Joint (SIJ).
✓ CFL products are being tested for various other applications such as
1. COVID, post-COVID related illnesses,
2. COPD,
3. All joint related pain,
4. Duchenne muscular dystrophy,
5. Type 1 and Type 2 diabetes,
6. Cosmetic facial applications,
7. Ulcerative Colitis, Crohn's, etc.
8.Auto-immune diseases and much more.
Why Our Products are superior
Registered and regulated by the Food and Drug
Administration (FDA). All cord blood donors are
screened against the FDA’s eligibility criteria.
We follow the highest standards established for
cord blood banking
1. National Marrow Donor Program® (NMDP).
2. World Marrow Donor Association® (WMDA).
3. Association for the Advancement of Blood &
Biotherapies (AABB)
4. We are licensed in all states that require a license
and approved for collections in all 50 US states.
5. Currently seeking our American Association of
Tissue Banks (AATB) license.
The above screening process enables us to qualify
around 50% of the cord blood that we collect
compared to others who process over 95%.