Studies

ENROLLING STUDIES ON CLINICAL TRIALS.GOV

Clinical Trials Protocols:

Amyotrophic Lateral Sclerosis:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Amyotrophic Lateral Sclerosis

Description:

Amyotrophic lateral sclerosis is a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and can improve the prognosis of afflicted patients. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for ALS. Patients with ALS will receive three intrathecal injections of UC-MSCs. The dose for each injection will be 50 million cells and the injections will be at two-month intervals. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Amyotrophic Lateral Sclerosis.
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Anticoagulation medicine use
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Previous organ transplant
• Hypersensitivity to sulfur
• Continued drug abuse
• Pre-menopausal women not using contraception

Multiple Sclerosis:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Multiple Sclerosis

Description:

Multiple Sclerosis (MS) can be a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and efficacious for the treatment of MS. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for MS. Patients with MS will receive a single intravenous infusion of UC-MSCs. The dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Multiple Sclerosis
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant

Hypersensitivity to sulfur

Autism:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Autism. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for Autism. Patients with Autism will receive a single intravenous infusion of UC-MSCs. The total dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Autism

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety
• Previous organ transplant
• Seizure disorder
• Hypersensitivity to sulfur

Rheumatoid Arthritis:

Safety of Cultured allogeneic adult umbilical cord derived mesenchymal stem cell Intravenous Infusion for the treatment of Rheumatoid Arthritis

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). This Patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for RA. Patients with RA will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Diabetes:

Safety of Cultured allogeneic adult umbilical cord derived mesenchymal stem cell Intravenous Infusion for the treatment of Diabetes

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Diabetes. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for Diabetes. Patients with Diabetes will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Diabetes
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Inflammatory Bowel Disease:

Safety of Cultured allogeneic adult umbilical cord derived mesenchymal stem cell Intravenous Infusion for the treatment of Inflammatory Bowel Disease

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of inflammatory bowel disease (IBD). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for IBD. Patients with IBD will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Crohn's disease or Ulcerative Colitis
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Systemic Sclerosis:

Safety of Cultured allogeneic adult umbilical cord derived mesenchymal stem cell Intravenous Infusion for the treatment of Systemic Sclerosis

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Systemic Sclerosis. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for Systemic Sclerosis. Patients with Systemic Sclerosis will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Systemic Sclerosis
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Idiopathic Pulmonary Fibrosis:

Safety of Cultured allogeneic adult umbilical cord derived mesenchymal stem cell Intravenous Infusion for the treatment of Idiopathic Pulmonary Fibrosis

Description:

Studies have shown that stem cell treatment is safe for Idiopathic pulmonary fibrosis (IPF) and can improve the prognosis of afflicted patients. This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for IPF. Patients with IPF will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Idiopathic Pulmonary Fibrosis
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant

Hypersensitivity to sulfur

Aging Frailty:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Aging Frailty. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Frailty. Patients with Frailty will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Aging Frailty
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant

Hypersensitivity to sulfur

Spinal Cord Injury:

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intrathecal Injection for Spinal Cord Injury

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Spinal Cord Injury
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Anticoagulation medicine use
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Previous organ transplant
• Hypersensitivity to sulfur
• Continued drug abuse
• Pre-menopausal women not using contraception

Lupus:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Lupus. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Lupus. Patients with Lupus will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Lupus
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Chronic Kidney Disease:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Chronic Kidney Disease

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Chronic Kidney Disease (CKD). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CKD. Patients with CKD will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Chronic Kidney Disease
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant

Hypersensitivity to sulfur

Traumatic Brain Injury:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Traumatic Brain Injury

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Traumatic brain injury (TBI). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of TBI. Patients with TBI will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of traumatic brain injury
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur
• Seizure disorders

Cerebral Palsy:

Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Intravenous Infusion for Cerebral Palsy

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Inclusion Criteria:

• Diagnosis of Cerebral Palsy

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety
• Previous organ transplant
• Seizure disorder
• Hypersensitivity to sulfur

Cerebral Palsy:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Cerebral Palsy

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Cerebral Palsy (CP). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CP. Patients with CP will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Criteria

Inclusion Criteria:

• Diagnosis of Cerebral Palsy

Exclusion Criteria:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety
• Previous organ transplant
• Seizure disorder
• Hypersensitivity to sulfur

Recent Completed Studies

Injection of Autologous Mesenchymal Cells for the Treatment of Arthritis has so far been Found to be Completely Safe

Background: Injection of autologous mesenchymal stem cells (AMSCs) as stromal vascular fraction, culture expanded adipose derived stem cells, minimally manipulated fat graft, bone marrow aspirate or cultured bone marrow MSCs, for osteo- and inflammatory arthritis have shown good clinical efficacy in many studies. Questions have been raised as to their safety despite no evidence known to us that they are unsafe when used this way. We hypothesized that AMSC injections are completely safe for the treatment of arthritis.

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Autologous Biologic Treatment with Fat, Bone Marrow Aspirate and Platelet Rich Plasma Is an Effective Alternative to Total Knee Arthroplasty for Patients with Moderate Knee Arthrosis

Background: Osteoarthrosis (OA) of the knee afflicts millions worldwide. Total Knee Arthroplasty (TKA) is common, but associated with substantial cost and morbidity. Prior studies of intra-articular injection of fat, bone marrow aspirate (BMA), and platelet rich plasma (PRP) have shown clinical benefit. We hypothesized that injection of autologous adipose tissue, BMA, and PRP would provide significant benefit for patients with moderate knee OA resulting in avoidance of total knee arthroplasty (TKA) in most, with discontinuance of NSAIDs and other drugs.

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Autologous Mesenchymal Stem Cell Treatment is Consistently Effective for the Treatment of Knee Osteoarthritis: The Results of a Systematic Review of Treatment and Comparison to a Placebo Group

Background: Numerous studies have used autologous mesenchymal stem cell injections (AMSCI) to treat osteoarthritis. We hypothesized that AMSCI is an effective osteoarthritis treatment with increasing efficacy at higher doses.

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Low Level Laser – Combined Intra-articular Laser and Platelet Rich Plasma (PRP) Injection Reduces Pain in Patients Who Had Failed Prior PRP Treatment Presented at the World Association for Laser Therapy Biennial Meeting in Nice France October 3-5 2018

Stem Cell - Autologous Biologic Treatment with Fat, Bone Marrow Aspirate and Platelet Rich Plasma Is an Effective Alternative to Total Knee Arthroplasty for Patients with Moderate Knee Arthrosis. Accepted for publication in Medicines

Platelet Rich Plasma - Successful, Non Surgical Treatment of Rotator Cuff Tears with PRP (Platelet-Rich Plasma) Injections (in preparation for submission for publication)

Orthopaedic Surgery – Treatment of Type Two Slap Lesion With Anatomic Suture Anchor Repair Without Biceps Tenotomy Or Tenodesis (Published in the Open Orthopaedics Journal October 2018)

Stem Cell – Injection of Autologous Mesenchymal Cells for the Treatment of Arthritis has so far been Found to be Completely Safe. Submitted for publication

Stem Cell – Autologous Mesenchymal Stem Cell Treatment is Consistently Effective for the Treatment of Knee Osteoarthritis: The Results of a Systematic Review of Treatment and Comparison to a Placebo Group. Submitted for publication

Research Studies in Progress

PRP Stem Cell

1. A new classification system for Shoulder Arthrosis Using the True AP or Grashey Radiographic View and comparison to traditional shoulder radiographs
2. Efficacy of PRP injection for Arthrosis of the Glenohumeral Joint
3. The efficacy of combined intra-tendinous and intra-articular PRP Injection for rotator cuff injury

1. The effects of Varus and Valgus Angulation on the Results of Stem Cell and PRP Injection in the Arthritic Knee
2. The Efficacy of Stem Cell and PRP Treatment for Knee Arthrosis as a function of joint space preservation
3. Efficacy of PRP injection for the Treatment of Patellofemoral Arthrosis
4. Efficacy of PRP injection for the Treatment of Patellofemoral Chondromalacia

The efficacy and safety of PRP injection for TMJ degeneration

The Benefit of PRP plus intra-articular laser compared to PRP alone for the treatment of first carpometacarpal arthrosis

Laser

The Efficacy of Low Level Laser Therapy for the treatment of Low Back Pain

The efficacy of PBM/LLLT for the treatment of neck pain

The Efficacy of Low Level Laser Therapy for Treatment of Disorders of theTemporomandibular Joint

Research Studies in Preparation

PRP – Stem Cell

1. The effect of intra-articular effusion on the results of treatment of arthrosis of the knee with PRP or stem cell injection
2. The efficacy of intra-articular and intravenous stromal vascular fraction injection on osteoarthrosis
3. The efficacy of intravenous stromal vascular fraction in lowering blood glucose levels in type 1 and type 2 diabetes
4. The efficacy of intravenous stromal vascular fraction injection in the treatment of rheumatoid arthritis
5. The efficacy of intravenous stromal vascular fraction injection in the treatment of sero-positive autoimmune diseases

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