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Stem Cell Therapy for Parkinson's Disease (HBPD04 Trial)
HBPD04 Trial Summary
This trial is a phase 2 study testing the efficacy and safety of allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease. Up to 60 participants will be enrolled, with a screening period of up to 4 weeks, a 32- week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration.
HBPD04 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHBPD04 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HBPD04 Trial Design
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Who is running the clinical trial?
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- I will use birth control during and for 6 months after the study if my partner can get pregnant.I am not pregnant or breastfeeding and use effective birth control.My Parkinson's disease is advanced, leaving me severely disabled or unable to leave my bed or wheelchair.I do not plan to donate sperm during or within 6 months after the study.I have hepatitis B, C, or HIV.I take less than 1400 mg of Levodopa or its equivalent daily.I am not pregnant and do not plan to become pregnant during the study and for 6 months after.I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.I take less than 1200 mg of Carbidopa/Levodopa daily.I haven't taken antibiotics, antivirals, or antifungals for an infection in the last 30 days.I do not plan to donate eggs or have IVF within 6 months after the last dose.I am willing and able to follow the clinical trial's requirements.I have not had any stem cell treatments in the last 6 months, except those from Hope Biosciences.I was diagnosed with Parkinson's disease at least 2 years ago.I am between 45 and 80 years old.
- Group 1: Allogeneic HB-adMSCs.
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
May I be accepted as a participant in this clinical trial?
"The enrolment criteria for this clinical trial demands that applicants are between 45-80 years of age, have been diagnosed with early and/or moderate Parkinson's disease at least 2 years ago, a MDS-UPDRS part II score ranging from 7 to 28, an MDS-UPDRS part III score between 20 and 57 during the screening visit, Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants., The total Levodopa equivalent dose for study participants must be less than 1400 mg per day., Female subjects should not become pregnant or conceive in the 6 months following their last"
What aims are the researchers attempting to achieve from this experiment?
"The primary endpoints of this trial are to determine changes in respiratory rate over a 52 week period. Secondary variables include modifications in muscle spasm visual analog scale, pain VAS, and alterations to medications taken by participants."
Is it feasible to enroll individuals of eighteen years or older in this trial?
"According to the study's requirements, only those aged 45-80 may apply for enrollment. However, there are 27 trials available for minors and 486 studies that cater to elderly adults."
Is this research pioneering in its field?
"Since 2020, Allogeneic HB-adMSCs has been studied in an effort to gain regulatory approval. Hope Biosciences was the first organization to sponsor a trial and after 24 participants, Phase 1 & 2 drug status was attained. At present time, 6 trials are ongoing across 4 cities and one nation."
How many people have opted to join this investigation?
"Affirmative, the clinicaltrials.gov listing states that this research is actively enlisting participants. It was initially posted on July 16th 2021 and recently updated September 20th 2022. There are 60 spots available at a single medical centre."
Is this research currently enrolling participants?
"The trial's listing on clinicaltrials.gov suggests that this experiment is still in need of participants, having gone live on July 16th 2021 and been revised most recently a month ago."
Are there any previous investigations involving Allogeneic HB-adMSCs?
"Currently, 6 studies involving Allogeneic HB-adMSCs. are being conducted with none at Phase 3. While many of the trials are administered from Sugar Land, Texas, there exist 7 other places where these medical experiments take place."
What are the associated risks of utilizing Allogeneic HB-adMSCs?
"The safety rating for Allogeneic HB-adMSCs was assigned a score of 2, given the Phase 2 trial nature of this medication and lack of efficacy data."
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