Stem Cell Therapy For DDD at NovoClinic
In partnership with Dr. Neil Riordan's Stem Cell Institute
Eligible patients are invited to participate in our cutting-edge, IRB-approved clinical trial evaluating the safety and efficacy of mesenchymal stem cell (MSC) therapy for the treatment of symptoms associated with Degenerative Disc Disease (DDD), in accordance with the approved protocol.
Treatment Protocol for Symptomatic Degenerative Disc Disease (DDD)
This advanced protocol aims to reduce pain, enhance mobility, and promote tissue regeneration in patients with symptomatic Degenerative Disc Disease (DDD).
Utilizing Dr. Neil Riordan’s therapeutically proven umbilical cord-derived mesenchymal stem cell (UC-MSC) therapy in accordance with IRB-approved clinical guidelines.
01. Treatment Goals
Objectives of the Treatment Phase
Mesenchymal stem cells derived from the umbilical cord (UC-MSCs) can be used to address disc degeneration, inflammation, and musculoskeletal dysfunction. At NovoClinic, a commonly administered treatment includes:
- Intradiscal Injection – Direct delivery to degenerative discs, which is the main objective of the therapy.
- Intramuscular Injection – Targeting spinal muscles for enhanced recovery.
- Epidural Injection – Targeting the area around the nerves, for pain and inflammation reduction.
- Facet Injection – An intra-articular injection that will help the facet joints affected by the degenerated disc, which are also considered a source of pain.
This therapy approach is considered a synergistic treatment of the Degenerative Disc Disease and lumbar pain, addressing not only the disc but all the structures surrounding it with the objective of treating not only the pain symptoms but the anatomy of all the treated segment(s).
02. Our primary objectives for stem cell therapy are:
Pain Reduction
Functional Improvement
Tissue Regeneration
Non-Invasive Treatment
03. Treatment Timeline
Start Your Application
Patient Onboarding
Our patient onboarding process facilitates a coordinated transition from initial consultation to post-treatment follow-up, in accordance with a standardized protocol and defined schedule:
- Pre-Treatment Consultation – Comprehensive assessment, including MRI review.
- Arrival & Preparation – On-site evaluations and pre-treatment medical evaluations.
- Stem Cell Administration – Targeted therapy application, as per approved protocol.
- Recovery & Follow-Up – Continuous monitoring at 1, 3, 6, and 12 months.
Who qualifies for treatment?
Patients considered for treatment must have:
- A diagnosis of lumbosacral pathology with MRI evidence performed within the previous 6 months from the application date
- Pain in the lumbosacral area with persistence of symptoms
- Willingness to complete the follow-ups as per approved Protocol
04. Qualifying Criteria
Inclusion Criteria
- Patients older than 18 years
- MRI imaging less than 6 months demonstrating degeneration of at least one intervertebral disc from L1 to S1, with at least one suspected disc causing chronic low back pain
- Symptomatic moderate-to-severe low back as defined by back pain with or without radicular pain lasting at least 6 months
- Failed conservative therapy or interventional therapy or surgery, including fusion
Exclusion Criteria
- Female participants who are pregnant or nursing, or women planning to become pregnant in the first 12 months post-treatment
- Any lumbar intradiscal injection, including steroids into the index or adjacent discs, facets and paraspinal muscles 2 weeks prior to intervention, with exception of the following injections performed at least 2 weeks prior study treatment:
- Contrast medium (discography or other diagnostic injections)
- NSAIDS
- Nerve-blocking anesthetics
- Antibiotics
- Saline
- Intolerance or allergy to local and total IV anesthesia
- Patients with severe central canal stenosis with neurogenic bowel/bladder or progressive weakness and other neurologic changes
05. The Science Behind Our Treatment
1. Tissue Collection
Umbilical tissue is collected from ethical donations.
The tissue undergoes stringent quality assurance and certification in accordance with regulatory norms.
2. Initial processing
Enzymes are applied to digest tissue and extract MSCs.
Once they are extracted, the MSCs are isolated for culture and expansion.
3. First Cellular Expansion
Once the initial culture of MSCs has reached an adequate cell count for storage and further expansion, it undergoes viability monitoring and quality control measures.
4. Cell Master Bank
A Cell Master Bank (CMB) is created with selected cellular lines.
This is to assure genetic stability and functionality of the selected cellular lines.
5. Large scale Expansion
The MSCs undergo mass production from the CMB.
Rigorous quality control procedures are used. Including cell viability assay, microbial contamination analysis, endotoxin assay, assessment of cell identity, and therapeutic potency.
6. Transport MSCs to Grand Cayman
The MSCs are then transported to Grand Cayman in strictly controlled conditions to ensure long-term cell viability.
This is done in compliance with shipping regulations and storage of live cells.
7. Administration of MSCs to patients
The final step is to administer the IV infusion to the patient at NovoClinic in Grand Cayman. The team will then conduct post-treatment monitoring and evaluation of the patients’ therapeutic response.
Scientific Rationale for Treatment
Mesenchymal stem cells (MSCs) exhibit regenerative, anti-inflammatory, and immunomodulatory properties through the secretion of bioactive molecules.
These characteristics position MSCs as a promising therapeutic modality for a range of medical conditions, as demonstrated by numerous studies and clinical trials supporting their safety and efficacy.
To date, the Stem Cell Institute has administered over 55,000 umbilical cord-derived MSC (UC-MSC) treatments with no reported serious adverse events.
Two peer-reviewed trials have been published investigating the use of stem cells to treat Degenerative Disc Disease:
- Phase II clinical trial (100 patients): Patients receiving stem cell injections experienced significantly greater pain relief and improved function. These improvements lasted for 36 months.
- Comparative trial (80 patients): Patients receiving stem cell injections directly into the affected areas (discs, joints, nerves) showed significant improvements in pain and function compared to those receiving standard treatments.
In both trials, the procedure was safe with few or no adverse events.
06. Safety & Regulatory Compliance
Safety Profile of Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) demonstrate a highly favorable safety profile, as documented in multiple clinical studies. To further ensure patient safety and therapeutic efficacy, comprehensive quality control measures are implemented throughout the entire process—from cell sourcing and manufacturing to patient monitoring.
Our umbilical cord–derived mesenchymal stem cells (UC-MSCs) are procured and produced under stringent regulatory standards in partnership with Signature Biologics, an advanced facility specializing in cellular therapeutics and biologics, based in Dallas, Texas.
Rigorous Quality Control & Compliance
Manufactured under cGMP and cGTP Standards
ISO 9001:2015 Certified
AATB-Accredited Tissue Bank
FDA & International Standards
Dr. Neil Riordan's Stem Cell Institute's Cellular Laboratory Adheres to GMP Standards
Stem Cell Institute production facilities are located in the USA and Adhere to GMP Standards for Safe and High-Quality Cell Therapies
In the development of cell therapy products for clinical use, adhering to Good Manufacturing Practice (GMP) standards is essential. These rigorous guidelines ensure the purity, identity, and potency of cell-based therapies, guaranteeing that every product meets the highest standards of quality and safety.
GMP-compliant manufacturing establishes a highly controlled and meticulously documented system, ensuring the consistency and reliability of cell therapy products. This is not only a critical requirement for regulatory approval but also a fundamental safeguard for patients, as these therapies involve living cells with significant potential in regenerative medicine.
As cell therapies transition from research to clinical applications, strict adherence to GMP standards remains a cornerstone for delivering science-backed, high-quality treatments that prioritize patient safety.
Cutting Edge Technology
- Innovative Manufacturing Techniques: Signature Biologics employs cutting-edge methods to produce human cellular and biologic products, ensuring that our stem cell therapies are at the forefront of medical innovation.
- Viability: Our automated cell counters provide rapid, consistent, and reproducible counts and assessments of MSCs. With these advanced tools, we can determine live versus dead cells, total and viable cell concentrations, and verify counts through integrated imaging.
Leadership in Stem Cell Research
Our team includes pioneers in applied stem cell research, bringing over 20 years of experience to our manufacturing processes. There have been no reported immune-related reactions or severe adverse effects.
- Compliant with FDA, ISO, and international tissue product standards.
Meet our
Stem Cell Therapy For DDD Providers
Through this collaboration, we ensure that our stem cell products meet the highest standards of quality, safety, and efficacy, providing our patients with cutting-edge regenerative therapies.
Dr. Tejas Ozarkar
Board Certified Interventional Pain Physician and Physiatrist
Dr. Wai Yoon
Consultant Spinal Surgeon and Consultant Pediatric Spinal Surgeon
Prof. Ali Noorani
Consultant Trauma & Orthopaedic Surgeon Shoulder, Elbow & Upper Limb Specialist
In collaboration with Dr. Neil Riordan's Stem Cell Institute
07. Clinical Trial Protocol & Eligibility Information
Clinical Trial Protocol & Safety
Our treatment for Degenerative Disc Disease in Grand Cayman is conducted in accordance with a stringent research protocol under an IRB-approved clinical trial (Study #SIG004-DDD), officially registered with the government of the Cayman Islands.
This framework ensures adherence to the highest standards of safety, ethical conduct, and regulatory compliance.
The treatment protocol is informed by the Stem Cell Institute’s extensive experience, having performed over 55,000 procedures for thousands of patients annually at our world-class facility in Panama.
This established track record encompasses successful completion of multiple clinical trials and provides a foundation of clinical expertise and real-world experience in the administration of cellular therapies.
Eligibility Criteria
Stem cell therapy is offered to patients diagnosed with Degenerative Disc Disease (DDD), with optimal outcomes observed in those without significant nerve compression or excessive neuropathic pain. Inclusion criteria are as follows:
- Age over 18 years
- MRI-confirmed evidence of disc degeneration within the past 6 months
- History of moderate-to-severe chronic low back pain persisting for a minimum of 6 months
- Failure to respond to conservative, interventional, or surgical treatment modalities
08. The Process
1.
Application Process
Upon determination of eligibility and approval of your application, your treating physician will develop and review a comprehensive, individualized treatment plan with you.
2.
Receive Treatment
3.
Follow Up
After treatment, our team will follow up with you at regular intervals to monitor your progress and provide ongoing support.
Get Started Today
We are committed to providing a safe, scientifically backed, and patient-focused treatment experience.
Trusted by over 15,000 patients worldwide and backed by more than two decades of pioneering stem cell research. Our treatments are developed in collaboration with leading stem cell scientists and manufactured under the highest quality standards.
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