Primary Outcome Measures:
Patients will be assessed for their capacity to tolerate IV infusion of MSC without acute clinical or physiological deterioration.
Vital signs, pulmonary function tests (FEV1 and FCV) and Borg Dyspnea Index will be evaluated. Chest Radiograph, CBC and serum chemistry will be performed.
The overall clinical development strategy of this project is to conduct this Phase I dose escalation study entitled "A pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells to Induce Remission in Lung Transplant Patients Experiencing Treatment-Refractory Moderate Lung Rejection". This study will be performed under this current IND application and will be limited to the proposed 9 subjects (3 subjects in each of dose escalating subject cohorts).
In this application we are proposing to evaluate safety and feasibility of allogeneic, bone marrow (BM) derived mesenchymal stem cells (MSC) to induce remission of moderate treatment refractory bronchiolitis obliterans (BO/BOS). Lung transplant patients with treatment refractory BO/BOS (grade 3) who do not qualify for a second transplant have near 100% mortality or extreme disability. MSCs are multi-potent cells that have the capacity to induce tissue repair and modulate immune response. They have been used successfully in preclinical and clinical studies to treat graft versus host disease (GVHD) and inflammatory bowel disease. Patients that progressed to moderate BO despite adequate medical treatments and who do not qualify for a second transplant will receive intravenous treatments of allogeneic MSC. The safety measure will include tolerance of MSC infusion and absence of significant cardiopulmonary compromise. The feasibility assessment will include ease of recruitment, practical issue of transporting, preparing and infusing the MSCs.
The clinical assessment from this initial safety study is intended to demonstrate safety of human MSC in subjects with BO and to evaluate the cell dose that demonstrates signs of efficacy. Pending favorable safety results and pharmacokinetic and pharamcodynamic data obtained in the current proposed study we will likely conduct additional human studies with a more directed focus on the evaluation of efficacy while collecting additional safety information.
Read the original post:
Mesenchymal Stem Cell Therapy for Lung Rejection - Full ...
- More Stem Cells Extracted For Later Use For My MS - March 14th, 2011 [March 14th, 2011]
- Stem Cell Institute Panama City Panama - April 1st, 2011 [April 1st, 2011]
- Cells That Heal Us From Cradle To Grave: A Quantum Leap in Medical Science - April 8th, 2011 [April 8th, 2011]
- Macular Degeneration Improved With Stem Cells - April 8th, 2011 [April 8th, 2011]
- Stem Cell Therapy for Kidney Failure - April 15th, 2011 [April 15th, 2011]
- SIRA: Could Stem Cell Therapy Renew Your Body Cells? - April 22nd, 2011 [April 22nd, 2011]
- Stem Cell Therapy for Autism - May 20th, 2011 [May 20th, 2011]
- Stem Cell Therapy for Critical Limb Ischemia - May 21st, 2011 [May 21st, 2011]
- STEM CELLS FOR MACULAR DEGENERATION Sam Smith's story.wmv - May 21st, 2011 [May 21st, 2011]
- Stem Cell Therapy Success - May 21st, 2011 [May 21st, 2011]
- Doctors Use Stem Cells to Grow New Windpipes - May 21st, 2011 [May 21st, 2011]
- Dog Undergoes Stem Cell Therapy - May 23rd, 2011 [May 23rd, 2011]
- Stem Cell Therapy for Multiple Sclerosis - May 23rd, 2011 [May 23rd, 2011]
- Dogs now getting stem cell therapy - May 24th, 2011 [May 24th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - May 30th, 2011 [May 30th, 2011]
- Stem Cell Therapy for Type II Diabetes - May 31st, 2011 [May 31st, 2011]
- Stem Cell Therapy for Cerebral Palsy - May 31st, 2011 [May 31st, 2011]
- Visions Episode 92: Stem Cells Discovery - May 31st, 2011 [May 31st, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia - June 1st, 2011 [June 1st, 2011]
- Stem Cell Patient Richard H. MS Treatment - June 10th, 2011 [June 10th, 2011]
- Stem Cell Therapy Injections - June 12th, 2011 [June 12th, 2011]
- Stem Cells Used to Grow Windpipes - June 20th, 2011 [June 20th, 2011]
- Stem Cell Therapy for Stroke - Gary Steinberg, Stanford University - June 21st, 2011 [June 21st, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Approach - June 23rd, 2011 [June 23rd, 2011]
- Stem Cell Therapy Cream: Less Wrinkles In 30 Days or Less Anti-Wrinkle Cream That Works - June 26th, 2011 [June 26th, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again - June 27th, 2011 [June 27th, 2011]
- Clinical Advances in Adult Stem Cell Therapy: Dr. Jorge Paz - June 27th, 2011 [June 27th, 2011]
- Stem Cell Injection Treatment - Stem Cell Therapy - June 27th, 2011 [June 27th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl - June 27th, 2011 [June 27th, 2011]
- Documentary: Stem Cell Therapy for Muscular Dystrophy - Ryan Benton's Story - June 30th, 2011 [June 30th, 2011]
- Stem Cell Therapy--Hillcrest Animal Hospital - July 14th, 2011 [July 14th, 2011]
- WAVE3 News Adipose Stem Cell Therapy - July 20th, 2011 [July 20th, 2011]
- Lou Gehrig's Disease (ALS): Stem Cell Therapy - A Patient's Perspective - July 23rd, 2011 [July 23rd, 2011]
- University of Melbourne announce Stem Cells Discovery - July 28th, 2011 [July 28th, 2011]
- Stem Cell Therapy (Regenerative Medicine) in New Jersey - August 9th, 2011 [August 9th, 2011]
- Spinal Cord Injury - Stem Cell Therapy - August 9th, 2011 [August 9th, 2011]
- Dr. Craig Saunders Adult Stem Cell Therapy - August 9th, 2011 [August 9th, 2011]
- Embryonic stem cell therapy in China (www.esctherapy.com) - August 13th, 2011 [August 13th, 2011]
- Mesenchymal stem cells and marrow stromal cells - August 15th, 2011 [August 15th, 2011]
- Mesenchymal Stem Cells in Regenerative Medicine: Of Hopes and Challenges - August 15th, 2011 [August 15th, 2011]
- Cardiomyogenic differentiation of Mesenchymal Stem cells (KUM2/9-15c) - August 15th, 2011 [August 15th, 2011]
- SENS4 - Engineered Mesenchymal Stem Cells - The Road to Skeletal Tissue Regeneration (1/3) - August 15th, 2011 [August 15th, 2011]
- Mesenchymal stem cells and marrow stromal cells---2nd--- - August 15th, 2011 [August 15th, 2011]
- Cadiomyogenesis of human mesenchymal stem cells - August 15th, 2011 [August 15th, 2011]
- Mesenchymal Stem Cells Transplantation In Heart.wmv - August 15th, 2011 [August 15th, 2011]
- Ying Liu discusses IPS cell therapy for ALS - August 15th, 2011 [August 15th, 2011]
- Non-controversial Stem Cells: Rationale for Clinical Use: Neil Riordan, Ph.D. - Miami, FL - August 16th, 2011 [August 16th, 2011]
- From Surgical Repair to Stem Cell Repair: A Surgeon's Journey by Leonard Smith MD, FACS - August 16th, 2011 [August 16th, 2011]
- Bone Marrow Aspiration - Stem Cell Therapy - August 16th, 2011 [August 16th, 2011]
- Non-controversial Stem Cells: Rationale for Clinical Use - Dr. Neil Riordan - August 16th, 2011 [August 16th, 2011]
- TEDxSingapore - Susan Lim - Hype and hope of stem cell research - August 16th, 2011 [August 16th, 2011]
- Cryo-Lip Instruction Video.VOB.flv - August 16th, 2011 [August 16th, 2011]
- Stem Cells Repair Damaged Heart [7-07-2011] - August 16th, 2011 [August 16th, 2011]
- Andalusian Stem Cell Bank - August 16th, 2011 [August 16th, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 - August 16th, 2011 [August 16th, 2011]
- Mesenchymal Stem Cells Drive New MS Study/Treatment - August 26th, 2011 [August 26th, 2011]
- Sims 2 Mafia Story Part 7 - Farewell, Godfather/Stem Cell Medicine - August 28th, 2011 [August 28th, 2011]
- STEM CELLS - Mesenchymal Stem Cells (Balzitt).flv - August 30th, 2011 [August 30th, 2011]
- Regenerative Medicine With Stem Cell Therapy Injections at an Arizona pain clinic (602) 507-6550 - September 3rd, 2011 [September 3rd, 2011]
- Stem Cell Research: Huntington's Disease - September 5th, 2011 [September 5th, 2011]
- Autism Stem Cell Trip - September 6th, 2011 [September 6th, 2011]
- Before/After Stem Cell for COPD: From Unable to Walk, to Dancing at My Daughter's Wedding - September 6th, 2011 [September 6th, 2011]
- Regenerative Medicine with Placenta Extracts and Stem Cell Therapies - Dr. Janethy Balakrishnan - September 6th, 2011 [September 6th, 2011]
- Stem Cells - September 6th, 2011 [September 6th, 2011]
- The Politics and Promise of Stem Cell Research - September 6th, 2011 [September 6th, 2011]
- Stem cell therapy in Guatemala - (closer than China) - September 7th, 2011 [September 7th, 2011]
- Stem Cell Therapy for Cerebral Palsy - Holly Catalano - September 9th, 2011 [September 9th, 2011]
- Clinical Advances in Adult Stem Cell Therapy - Dr. Jorge Paz Rodriguez (Miami) - September 9th, 2011 [September 9th, 2011]
- CryoLip Stem Cell Preservation - September 20th, 2011 [September 20th, 2011]
- Dr. Gonzalez tells his story of Stem Cell Treatment and Stem Cell Therapy - September 23rd, 2011 [September 23rd, 2011]
- A Three Minute Cell Passage - September 23rd, 2011 [September 23rd, 2011]
- Bone Marrow - Stem Cell Prolotherapy - September 23rd, 2011 [September 23rd, 2011]
- Stem Cell Therapy- Interview with Indian Surgeon - September 23rd, 2011 [September 23rd, 2011]
- Cryo-Lip.f4v - September 23rd, 2011 [September 23rd, 2011]
- CryoCord Corporate Video (2 Mins) - September 23rd, 2011 [September 23rd, 2011]
- SENS4 - Engineered Mesenchymal Stem Cells - The Road to Skeletal Tissue Regeneration (3/3) - September 23rd, 2011 [September 23rd, 2011]
- What are stem cells? - September 24th, 2011 [September 24th, 2011]
- Dental stem cell bank in Hyderabad - September 24th, 2011 [September 24th, 2011]
- Stem Cell Therapeutics: Tissue Regeneration - Christopher J. Centeno, MD - September 25th, 2011 [September 25th, 2011]
- Stem Cell Types and Sources - September 25th, 2011 [September 25th, 2011]